Specialty drug market access reality check · about which potential payer tactics have the highest...

Specialty drug market access reality checkTen payer pressures to act on now

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The debate unfoldsThe debate around the market access challenge for breakthrough innovation areas centers around two key issues.

The degree of pricing pressure that will be exerted by payers as new breakthrough products set records for total drug cost per patient per year.

The level of restrictions payers can realistically impose on access to new therapies in areas where mortality rates are high and current therapies are basically ineffective.

Although significant on a patient-by-patient level, the budget impact of any single specialty drug therapy or even disease market may be small overall. However, the combined spending across the breakthrough innovation space appears to be reaching unsustainable levels, a development that will inevitably result in more payer scrutiny into costs. To illustrate:

– Specialty patients represent less than five percent of the US population, but they account for 25 percent of payer and employer healthcare expenditures and 40 percent of total drug expenditures, according to a Milliman Research Report.1 And given the small size of the patient populations, specialty drugs represent only two percent of pharmaceutical prescriptions written, but 30 percent of all consumer drug spending.2

Specialty Patients

of US population of prescriptions

40%

25% 30%

5%

of payer/employer healthcare expenditures

of consumer drug spending

of payer/employer drug expenditures

Specialty Drugs

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1Debates about market access in the specialty

drug realm are heating up. This is especially true for products targeting indications with exceedingly high levels of medical need. These are the diseases we call “breakthrough innovation areas” since rapid advancements in the standard of care are either occurring or planned. Major breakthrough innovation drugs are being introduced to treat cancer, autoimmune diseases, rare genetic disorders, Alzheimer’s, and pandemic infectious diseases. Approaches to product development, marketing and pricing are already unique in these areas, and the landscape is still evolving.

2%

“More than half of CEOs rank new products and new customers as the most important sources of growth over the next three years.”

– 2016 KPMG CEO Outlook Survey

© 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Printed in the U.S.A. The KPMG name, and logo are registered trademarks or trademarks of KPMG International. 3Specialty drug market access reality check

Specialty Traditional

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Fig. 2 Specialty drugs dominate recent FDA approvals

Fig. 1 Specialty could grow to 50% of total drug spend Total spend at top of each bar

– Spending on specialty drugs has grown at more than 20 percent annually for the last five years.3 And by 2018, predictions hold that 50 percent of total drug spend will go to specialty drugs.4

– Over the past decade, specialty drugs have surpassed traditional drugs when it comes to FDA approvals (as shown in the chart below). And in 2014, the number of new NME drugs targeting specialty therapeutic areas totaled 27, which amounts to 70 percent of all drugs launched.5

One camp among pharmaceutical executives and functional experts—a group we call the idealists—maintains that, while payers will always scrutinize the cost of new therapies, innovations that make a true breakthrough will continue to have relatively high pricing flexibility and few restrictions on access for the foreseeable future. The other camp, which we call the realists, maintains that no disease area will be able to escape pricing and access challenges and that the reality of payer pressure must be taken seriously as launches are planned. As is often the case with opposing viewpoints, the truth is arguably somewhere between the two.

The Idealists make a credible argument that payers, no matter how cost focused, would have a difficult time limiting access to life-saving therapies when few or no alternatives exist. The public relations nightmare associated with rationing care for patients with the highest level of medical need is reason enough for payers to grant access to breakthrough drugs, no matter how high the price. Idealists also point out that

the budgetary impact of any one of these high-priced drugs is usually modest since they typically target patient populations in the tens of thousands within any given country market, in contrast to the millions of patients targeted by the blockbuster, primary care indications of the past.

The Realists counter with the argument that diseases for which a single breakthrough therapy remains the only viable treatment option are increasingly rare. Even in highly-targeted disease spaces—such as ALK+ non-small cell lung cancer or specific genotypes within the Hepatitis C Virus market —multiple pharmaceutical companies have introduced products with the same mechanisms of action and producing similar clinical outcomes. With a greater number of approved therapies to choose from, contend the realists, payers will eventually gain the upper hand, using the power of choice to push down net pricing and enforce their own therapeutic preferences. These preferences will be at least partly driven by the discounts and rebates manufacturers offer.

Two opposing camps

Certain breakthrough innovation areas may be immune to payer

leverage at first, but, in the long-term, no disease state with multiple

viable therapies will be spared. The ALK+ non-small cell lung cancer

and Hepatitis C Virus (HCV) markets are a case in point. In the ALK+

market, most payers have been unable to override physician choice

and differentially reimburse for one approved therapy over another.

However, in the US HCV market, there has been a much publicized

jockeying for near-exclusive formulary positioning between Abbvie’s

VikeraPak and Gilead’s Harvoni.

A Balanced View

Idealistic and realistic viewpoints on market access


Whether you are a market access idealist or a realist, it is hard to deny that payers will need to assert more influence over pricing and access in certain disease markets and geographic regions where competitive dynamics and budgetary metrics require their input. Market access teams throughout the pharmaceutical industry have been speculating about various doom and gloom scenarios, and senior management has engaged. Hypothetical scenarios range from gradual imposition of more demands for discounts in disease spaces that had been immune to contracting, to such extreme developments as the United States moving to a single payer system virtually overnight or the formation of a pan-European pricing and drug procurement body.

The problem is that the long list of possible threats to the current market access model leaves most organizations paralyzed when it comes to investing precious resources into future drug developments. What they need is a reality check about which potential payer tactics have the highest probability of coming to fruition and which would be most impactful to their portfolios. With a clear, aligned view on how the payer landscape will likely unfold, pharmaceutical organizations can address near-term market access challenges proactively and monitor others for future risk assessments.

Reality check:Some payer pressures are likely, some are decidedly not

Market access idealists vs. realists. Where do you stand?


Idealists Realists

Idealists Realists

5Specialty drug market access reality check

• Argue that truly breakthrough innovations will continue to have relatively high levels of

pricing flexibility and few restrictions on access for the foreseeable future.

• Contend that payers will continue to have a difficult time limiting access to vital, life-saving therapies when few or no alternatives exist.

• Point out that the overall budget impact of any single specially pharmaceutical agent is usually low.

• Advocate for R&D investments to support “first in class, best in class” positioning over spending to address market access threats.

• Assert that the threat of payer pressures on pricing and access, even in the breakthrough

innovation space, is here now and must be taken seriously as launches are planned for the future.

• Suggest that situations in which a single breakthrough therapy remains the only viable treatment option in any given disease over the long-term is increasingly rare.

• Argue that payers will always gain the upper hand eventually, using the power of choice to push down net pricing and enforce their own therapeutic preferences.

As a starting point for identifying the most pressing market access challenges, we offer our perspective on the near-term payer tactics that are most likely to affect the value of most pharmaceutical portfolios. To that end, we have grouped potential payer tactics into three categories (see figure on page 7). The dynamics that we believe are unlikely to emerge due to major implementation barriers are categorized as Deprioritize. The market dynamics that could emerge, but require further enablement from the market have been categorized as Watch & Wait. Most important, the ten critical dynamics that we believe should be systematically incorporated into all commercial strategy decisions are designated as Act Now. It is these dynamics that we elaborate on in the second half of this paper.

Hone your focusInvest resources in the most likely market access challenges


Act Now Watch & Wait DeprioritizeChange has already begun or

is imminent, requiringmanufacturers to consider

implications for all strategic decisions

Change has a high probability of occurring if certain barriers are eliminated, warranting close monitoring for need to act

Change is very unlikely to occur given major barriers; do not

prioritize for action unless market conditions change

1. Indication-based pricing

2. Winner-take-all contracting

3. Capitated payment by outcome

4. Narrower definition of “added benefit”

5. Cost-influenced treatment guidelines

6. Patient affordability barriers

7. Data-driven clinical pathways

8. Off-label utilization restrictions

9. Consolidation of drug procurement

10. Greater demand for lifecycle discounting

1. Outcomes-based contracting

2. Restriction of orphan and breakthrough designation

3. QoL included in Health Technology Assessments (HTA)

4. Demand for price transparency

5. Erosion of mandatory Medicare coverage

6. Medicare ACO contracts include drug spend

7. Japan HTA has meaningful impact on drug price

1. US participates in international reference pricing

2. US creates centralized pricing/HTA authority

3. Medicare has ability to negotiate drug prices

4. EU-wide HTA body

5. EU-wide drug procurement


Indication-Based Pricing: In many specialty therapeutic areas (e.g., autoimmune diseases, oncology), products can maximize their lifecycle value by expanding their indication footprint. However, products often show varying levels of efficacy across indications (both objectively and relative to competitors in each indication). As more products launch with significant variation in efficacy across lifecycle indications, payers will seek differential prices by indication (either via reductions in gross price or gross-to-net contracting) to equate price with outcomes to some extent. While this can lower prices in some scenarios, manufacturers can also realize enhanced value when the drug is used for indications that are less competitive, have high unmet need and realize improved treatment outcomes.

For example, Express Scripts is currently piloting indication-based pricing for certain cancer drugs and is looking at further adopting this discounting strategy going forward.6 In other words, reimbursement rates will be higher or access hurdles will be lower when drugs are prescribed for indications for which the overall clinical efficacy and cost-benefit ratio are compelling. The same drug may be subject to severe access restrictions in other indications where the clinical benefit is marginal and the budget impact is significant. The historic paradigm was to launch into and set pricing for smaller patient populations with high unmet need, followed by expansion into much larger, better served patient segments. However, this progression may become a relic of the past for certain drugs.

Winner-Take-All Contracting: As multiple products launch in a class, payers can create a winner-take-all environment in which competitors offer higher and higher discounts in exchange for exclusive or semi-exclusive formulary access. While this dynamic can be valuable for the winner(s), manufacturers should be cautious about creating a race to the bottom on price that even exclusive access cannot recoup. This dynamic will be especially common when it comes to products targeting very large patient populations, when there are multiple entrants launching within a short timeframe, and when there is limited clinical differentiation between products.

One recent success story related to formulary positioning occurred with the launch of Amgen’s PCSK-9 inhibitor, Repatha.7 Having launched within months of Sanofi and Regeneron’s Praulent, Repatha faced an uphill battle with US health insurers and pharmacy benefits managers (PBMs). To boost its standing in the marketplace, Amgen negotiated a novel discounting arrangement tied to patient outcomes with a regional health plan – Harvard Pilgrim Healthcare. Under the terms of the deal, Amgen is required to offer increased discounts on the standard discounted price of Repatha if members with statin-refractory hypercholesterolemia do not show decreased LDL levels within a set time period. In return, Amgen receives preferred status on Harvard Pilgrims’ drug formularies for commercial plans. The deal was followed by a similar arrangement with CVS, as well as a non-exclusive value-based arrangement with Cigna.8

The “Act Now” dynamics

Geographic Variation:

It is important to note that HTA-driven markets (EU and soon Japan) will be more likely to institute gross price changes, while the US is more likely to adopt indication-based contracting. It will be more feasible in the US for payers to track indication-specific usage of drugs, as prior authorizations are common for specialty drugs. This discipline will be more challenging for payers in certain EU markets and Japan.


In the US, competition for formulary access is likely to result in payer- and PBM-driven gross-to-net discounts. In the EU, aggressive and broad-based tenders will likely be the response of choice.

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Capitated Payments by Outcome: As combination therapy becomes the standard of care in many specialty therapeutic areas, the cost to achieve optimal outcomes is rising dramatically. This development is unsustainable for payers, particularly as these regimens are used as early lines of therapy. Payers may instead begin to require capitated payments for treating a given patient segment (e.g., first line NSCLC). This bundling would be similar to diagnosis related group (DRG) payments, as the price would remain constant regardless of the number of drugs required to achieve the outcome. While this reduced cost variability is beneficial for patients and payers, pharmaceutical manufacturers would lose pricing flexibility and need to navigate price tradeoffs between different agents in the regimen. (Of course this becomes even more complex when agents in the regimen are produced by different manufacturers.) This dynamic is more likely to emerge in therapeutic areas in which combination therapy has become or is becoming the standard of care (e.g., oncology, hepatology, HIV) and when volumes in any given patient segment are high enough to warrant a capitated payment model. It is, however, conceivable that all pharmaceutical markets will enact this strategy, given the precedent of capitated payments in other parts of the healthcare system and the growing acceptance of higher prices in the short term to ensure better outcomes and more controlled costs to treat a condition in the long term.

Narrower Definition of “Added Benefit”: As competition intensifies, unmet need wanes and budgets continue to be stretched, the level of clinical performance required to achieve meaningful added benefit over existing therapies will be more significant. Fewer products will be able to achieve this level of performance, and those that do not will have lower pricing potential or lower uptake than expected. This dynamic will be especially impactful for products in very crowded classes and those targeting early lines of therapy, where unmet need is lower.

Cost-Influenced Treatment Guidelines: Today, clinical treatment guidelines are developed by disease societies and focus on defining optimal clinical treatment of a disease, without consideration of cost. As drug prices and payer pressure on utilization increase, disease societies and key opinion leaders are taking notice of cost and incorporating it into guidelines. Given the reverence for these guidelines from community physicians, these changes will directly influence treatment decisions and require more direct tradeoffs between price and uptake. Further, payers will often refer to these guidelines when making formulary and utilization management decisions. This dynamic will be especially impactful for providers working in therapeutic areas that have not required cost of care management to date and where industry guidelines have a strong influence over prescribing decisions (e.g., oncology).


HTA-driven markets (EU and soon Japan) will implement this change more directly, through pricing and reimbursement decisions. The impact in the US will be more variable and driven by individual payers and healthcare delivery systems.


The impact of cost as a factor in treatment guidelines will be greater in the US market than in the EU or Japan. This is due to the fact that there is no formal HTA process in the US for managing price in parallel with clinical best practices.

9Specialty drug market access reality check

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The “Act Now” dynamics (continued)


This is also largely a US issue; patients in the EU have fewer problems with affordability given universal healthcare, lower drug prices, and low caps on out-of-pocket costs.

The “Watch and Wait” Dynamics

Another set of potential market dynamics could potentially impact pharmaceutical portfolios, but need to be watched until the market demands change. Several factors will likely prevent these dynamics from progressing to “Act Now” status in the near term:

– Regulatory Barriers: For many of these elements, one or more regulatory changes are required for payers to change their approach to market access issues (e.g., discontinuation of mandatory Medicare coverage, price transparency regulations). While some regulations have been proposed, the odds of passage and time to implement them if passed are still unclear.

– Precedent Barriers: In many cases, significant change to longstanding policies and processes would be required to support the new dynamic (e.g., how orphan / breakthrough status is granted, inclusion of QoL in HTA protocols) or the dynamic may currently be misaligned with the broader values of the healthcare system (e.g., HTA directly impacting drug prices in Japan). This could change if enough momentum emerges in a particular market.

– Feasibility Barriers: In other cases, feasibility is complicated under the current system. This can be due to a requirement for data or infrastructure not yet established, challenges with previous pilots, and/or lack of consensus on the action’s value. Full outcomes-based contracting, as opposed to the “one-off” outcomes-based pricing illustrated above, is a prime example of this dynamic: While in some specific situations there is alignment on value and available data for tracking outcomes, payers are ill-disposed toward such complicated arrangements and prefer more standard, simple contracts.

Despite these barriers, decision makers should not be caught off-guard by these dynamics and should actively monitor market changes that could allow them to take hold.


Patient Affordability Barriers: Patient cost has historically been of limited significance to access, given the prevalence of co-payments, low deductibles and patient assistance programs to defray out-of-pocket costs. As benefit designs change to include co-insurance, sky high drug-specific deductibles, and disincentives for financial assistance, patients are now fronting a much greater portion of their drug bill. This is compounded by the fact that the aging population is developing more chronic conditions that are being treated by one, if not multiple, expensive specialty drugs, creating unprecedented affordability challenges. This creates a new, potentially significant barrier to drug access that is difficult for manufacturers to overcome, given regulatory constraints on financial assistance. This dynamic will be especially impactful for non-oral products, where use of co-insurance is more common. However, ultimately costs will be driven more by patients’ health plan designs, which impact all drugs, rather than by an individual drug’s profile.

That said, there are several recent examples of new mechanisms of action with a few competitors gaining earlier and broader market access positioning by accepting some risk when it comes to net price. For example, Novartis’s congestive heart failure (CHF) drug Entresto was able to secure preferred formulary status with Aetna and Cigna by offering a variable discount plan based on whether the medication reduces hospital admissions for complications related to CHF. The elimination of market access barriers had the added benefit of increasing the likelihood that cardiologists would choose to prescribe Entresto versus their historic pattern of prescribing less-expensive, generic alternatives for CHF management.

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Data-Driven Clinical Pathways: Treatment guidelines are typically based on a comparison of data from pivotal trials by a clinical society, often with limited insight into real-world usage and implementation variations from practice to practice. To provide data-driven treatment guidelines for a given disease, pathways companies are emerging. These entities are poised to become the key influencers for access decisions as they analyze clinical trial data, generate real-world evidence, and evaluate cost trends. Decision-making will be more consolidated, as pathway companies and payers work together to develop formulary and utilization guidelines around the pathway and economically incentivize physicians to comply with the pathway (e.g., P4P programs). This dynamic is likely to be most impactful in therapeutic areas where the relative value of multiple drug options requires deeper analysis and where there is significant variation in physician prescribing dynamics (e.g., autoimmune diseases).

Off-Label Utilization Restrictions: Payers have historically implemented selective utilization restrictions to limit off-label use of drugs that might have a significant budgetary impact. More recently, however, utilization limits have increased. This is particularly true with high-priced drugs targeting large patient populations (e.g., second generation antivirals for HCV, immuno-oncology drugs). Payers see the need to limit off-label utilization to patients with the highest unmet need (sometimes supported by clinical guidance, other times not) to control costs. This creates significant barriers to access and limitations on value creation, forcing manufacturers to make tradeoffs between price/volume and the value a product brings to patients. These restrictions also have potential clinical ramifications, as early-stage patients could miss the opportunity to change the course of their disease by addressing it early on. Balancing all of these considerations is particularly challenging for payers in disease areas affecting large numbers of patients but with few effective drug options.


Pathway companies could arise in any market, but are most likely to emerge in the US due to a greater reliance on managing the relationship between budget impact and price via utilization restrictions. The EU and Japan have other mechanisms in place to manage this relationship.


While we expect this dynamic to emerge globally, it will be most acute in markets struggling to recover from the economic downturn and control healthcare expenditures (e.g., Spain, Italy).


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Greater Demand for Lifecycle Discounting: In the EU and increasingly in Japan, the lifecycle price adjustment is a common practice for curtailing a drug’s budget impact over time. This has not occurred in the US, as many drugs have commanded double-digit annual price increases, thus contributing to higher spending more than additional volume or new product launches. In the future, however, US companies will need to manage price more aggressively across product lifecycles in order to accommodate economic constraints. This may manifest in a demand for smaller price increases or greater discounts to balance price increases. Meanwhile, in the EU and Japan, there will likely be demand for greater price cutting, due to indication expansion and competitive changes. This dynamic will have the greatest impact in US markets with historically high price increases (e.g., oncology), significant indication expansion over the lifecycle (e.g., autoimmune drugs), and the emergence of biosimilars competition.

The “Act Now” dynamics (continued)

The “Deprioritize” Dynamics

Many troubling scenarios being discussed by market access Realists include one or more elements that are unnecessarily provocative and are unlikely to occur due to significant regulatory and/or feasibility hurdles.

For example, some would require development of new government bodies, which would involve an enormous investment and decades to enact. (Some examples of ideas that have been floated are a US-centralized pricing authority and an EU-wide HTA drug procurement assessment body.) Others would require a paradigm shift in core processes that would turn day-to-day operations upside down and/or negate core values of the healthcare system. (Some examples include the possibility of the US participating in international reference pricing, and Medicare engaging in drug price negotiation.)

While it is certainly possible that one or more of these dynamics could emerge in the long-term, it is unlikely that the industry will see the wide-sweeping change currently hypothesized. Only in the improbable scenario where major regulatory changes occur, political climates shift, and significant investments are made to change practices would some of these elements move to “Watch and Wait” status.

For now, manufacturers should focus their time and investments on more imminent, likely changes in the market access environment.


10Consolidation of Drug Procurement Drug procurement often occurs on a hospital-by-hospital or payer-by-payer basis, largely outside of national approval and reimbursement assessments. While leverage can be gained by utilizing the negotiating skills of a distributor or pharmacy benefits manager (in the US), there is still significant variation in the discounts different entities can command. Consolidation of healthcare systems (e.g., creation of large hospital networks on the local / regional level) and stakeholder transformation (e.g., in the US, health systems becoming payers) are allowing entities to more effectively negotiate lower drug prices. This dynamic will likely have a greater impact on drugs being sold into hospitals and in markets that have strong local or regional discounting (either in place of or in addition to national-level rebating).

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Incorporating “Act Now” dynamics into market access strategies for new products, and for those early enough in the lifecycle to enhance their positioning, should be a clear point of focus for both R&D and commercial decision-makers. However, we see several portfolio-level initiatives as equally critical to ensuring that product-level strategy development is as efficient and coordinated as possible. Therefore, one of the most critical considerations for pharmaceutical companies today is whether the market access function should remain siloed.

In most organizations, the market access organization is positioned as an advisor to other internal groups. Insights on the changing payer environment and evolving market access requirements are evaluated by a complex web of groups that may or may not choose to accept market access guidance

when it comes to initiating new clinical studies, launching real-world evidence pilots, adapting field force messaging, establishing pricing and contracting terms, or advocating for policy changes within legislative bodies.

Companies should consider a collaboration model between the market access function and other groups that contribute to the overall payer value proposition. Whether this means embedding the function within a larger group or creating an overarching “umbrella” group focused on positioning products for the evolving payer landscape will depend on the culture and structure of the company. However, maintaining the current siloed approach will not be sustainable as more complex market access dynamics unfold.

An important consideration:Redefining the market access function

Pharmaceutical companies are struggling with how and to what degree to prepare for the rapidly changing payer landscape, especially as they pertain to the treatment of breakthrough innovations for rarer diseases.

As rumor and misguided predictions abound about the measures payers will take to reign in drug costs, inertia can set in. However, companies that give in to this paralysis will be missing out on the opportunity to get ahead of the pack and address the very specific needs of different types of payer organizations and patients globally -- from private health insurers in the United States; to national health systems in Europe and Japan; to individual healthcare consumers across emerging markets in Asia, Latin America and Africa. Growth of the specialty drug market is inevitable. Companies would be wise to embrace this opportunity by putting wildly disruptive, but low-probability payer dynamics on the back burner and focusing on the most likely payer dynamics today.

Final thoughts


KPMG helps pharmaceutical companies weigh market access strategies in terms of feasibility and priority, integrate payer perspectives into R&D and commercial processes, anticipate and react to developments by commercial and government payers, and ensure that their products are well-positioned and supported by robust evidence of meaningful outcomes for cost. We work with companies on transforming the way they approach market access, new product development and portfolio management through our Nine Levers of Value methodology connecting business model design (strategy) and operating model implementation (execution). With senior practitioners dedicated to R&D and commercial strategy, regulatory affairs, risk consulting, and M&A advisory, our one firm approach to client engagements results in an enterprise-wide view from strategy through results.

Getting from strategy to resultsHow KPMG can help

References:

1. Holcomb, K. and Harris, J. (2015). Commercial Specialty Medication Research: 2016 Benchmark Projections, Milliman Research.

2. Institute for Healthcare Informatics (2015). Global Medicines Use in 2020: Outlook and Implications.

3. FDA, Goldman Sachs Global Investment Research.

4. IMS Health, CVS Analyst Day.

5. AHIP (2015). Specialty Drugs: Issues and Challenges: Advancing effective strategies to address soaring drug costs while ensuring access to effective treatments and promoting continued medical innovation.

6. Staton, T. (2015). Express Scripts rolls out value-based pricing for cancer meds, FiercePharma.

7. Herman, B. (2015). Harvard Pilgrim cements risk-based contract for pricey cholesterol drug Repatha, Modern Healthcare.

8. Palmer, E. (2015). Amgen’s Repatha scores an exclusive with CVS, FiercePharma.

9. Herman, B. (2016). Insurers, drugmakers wrestle with how to build value-based contracts, Modern Healthcare.


Peter Gilmore, Principal in KPMG Strategy, has more than 15 years of experience advising senior management teams at leading pharmaceutical, medical device, and consumer health companies. Peter supports life sciences clients on both transformation and optimization engagements, focusing on commercial and R&D issues related to resource portfolio management, commercial model innovation, market access, contracting, product development, and launch planning. He has evaluated numerous licensing and acquisition deals across 30+ disease categories, using advanced valuation models and decision-analysis methodologies. Peter is a graduate of Dartmouth College.

Amy Hunckler, Director in KPMG Strategy, has nearly 10 years of experience supporting leadership teams at biopharmaceutical, medical device, and diagnostics companies. Amy advises life sciences clients on a wide range of transformation and optimization issues, with particular expertise in market access, product development, and portfolio decision making. Amy has worked across dozens of therapeutic areas, with a heavy emphasis on core specialty markets including oncology, immunology, neurology, and rare disease. Amy is a graduate of Brown University.

About the authors


© 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. NDPPS 555298

The KPMG name and logo are registered trademarks or trademarks of KPMG International.

Some or all of the services described herein may not be permissible for KPMG audit clients and their affiliates.

kpmg.com/socialmediaThe information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act upon such information without appropriate professional advice after a thorough examination of the particular situation.

Contact Us

Peter GilmorePrincipal, KPMG [email protected]

Amy HuncklerDirector, KPMG [email protected]

To learn more about our Healthcare & Life Sciences practice and capabilities, visit us at kpmg.com/us/healthcarelifesciences

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