Scottish Health Secretary directs SMC to be "more flexible"

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PharmacoEconomics & Outcomes News 689, p11 - 19 Oct 2013 Scottish Health Secretary directs SMC to be "more flexible" As part of a revamp to the drug approval process in Scotland, the Health Secretary, Alex Neil, has directed the Scottish Medicines Consortium (SMC) to be "more flexible" when evaluating drugs for rare conditions and end-of-life care. 1 Announcing the changes – the first step in a wider process towards Scottish valued-based assessment – Mr Neil says that "it is only right that Scottish patients have access to medicines that are clinically justified". And he believes the changes will make the system "better and more open for patients". Additional improvements in the revamp include an extension to the £20 million Rare Medicines Drug Fund until 2016, and the creation of new approval system allowing doctors to prescribe drugs that are not accepted for routine use by the SMC. Recent SMC recommendations The announcement comes the day after the SMC accepted crizotinib [Xalkori] * for use in patients with previously treated anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. 2 However, on the same day, the SMC did not recommend pertuzumab [Perjeta], in combination with trastuzumab and docetaxel, for patients with HER2-positive metastatic or locally recurrent unresectable breast cancer because the additional cost did not justify the additional health benefits. Other drugs recommended at the same time include: granisetron transdermal patch [Sancuso] for preventing chemotherapy-induced nausea and vomiting; nalmefene [Selincro] for alcohol dependency; carglumic acid [Carbaglu] for the treatment of hyperammonaemia; and botulinum toxin type A [Botox] for urinary incontinence. * This decision is in contrast to the recent final guidance from NICE not recommending the drug because it was not cost effective; see PharmacoEconomics & Outcomes News 688 p11; 801085739 1. The Scottish Government. Improving access to new medicines. Media Release : 8 Oct 2013. Available from: URL: http://www.news.scotland.gov.uk. 2. Scottish Medicines Consortium. SMC advice: bimatoprost + timolol (Ganfort Unit Dose Preservative Free); botulinum toxin type a (Botox); carglumic acid (Carbaglu); crizotinib (Xalkori); granisetron (Sancuso); nalmefene (Selincro); pertuzumab (Perjeta). Internet Document : 7 Oct 2013. Available from: URL: http://www.scottishmedicines.org.uk. 801085744 1 PharmacoEconomics & Outcomes News 19 Oct 2013 No. 689 1173-5503/13/0689-0001/$14.95 Adis © 2013 Springer International Publishing AG. All rights reserved

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PharmacoEconomics & Outcomes News 689, p11 - 19 Oct 2013

Scottish Health Secretary directsSMC to be "more flexible"

As part of a revamp to the drug approval process inScotland, the Health Secretary, Alex Neil, has directedthe Scottish Medicines Consortium (SMC) to be "moreflexible" when evaluating drugs for rare conditions andend-of-life care.1

Announcing the changes – the first step in a widerprocess towards Scottish valued-based assessment –Mr Neil says that "it is only right that Scottish patientshave access to medicines that are clinically justified".And he believes the changes will make the system"better and more open for patients".

Additional improvements in the revamp include anextension to the £20 million Rare Medicines Drug Funduntil 2016, and the creation of new approval systemallowing doctors to prescribe drugs that are notaccepted for routine use by the SMC.

Recent SMC recommendationsThe announcement comes the day after the SMC

accepted crizotinib [Xalkori]* for use in patients withpreviously treated anaplastic lymphoma kinase-positiveadvanced non-small cell lung cancer.2 However, on thesame day, the SMC did not recommend pertuzumab[Perjeta], in combination with trastuzumab anddocetaxel, for patients with HER2-positive metastatic orlocally recurrent unresectable breast cancer because theadditional cost did not justify the additional healthbenefits.

Other drugs recommended at the same time include:granisetron transdermal patch [Sancuso] for preventingchemotherapy-induced nausea and vomiting;nalmefene [Selincro] for alcohol dependency; carglumicacid [Carbaglu] for the treatment of hyperammonaemia;and botulinum toxin type A [Botox] for urinaryincontinence.* This decision is in contrast to the recent final guidance from NICE notrecommending the drug because it was not cost effective; seePharmacoEconomics & Outcomes News 688 p11; 801085739

1. The Scottish Government. Improving access to new medicines. Media Release :8 Oct 2013. Available from: URL: http://www.news.scotland.gov.uk.

2. Scottish Medicines Consortium. SMC advice: bimatoprost + timolol (GanfortUnit Dose Preservative Free); botulinum toxin type a (Botox); carglumic acid(Carbaglu); crizotinib (Xalkori); granisetron (Sancuso); nalmefene (Selincro);pertuzumab (Perjeta). Internet Document : 7 Oct 2013. Available from: URL:http://www.scottishmedicines.org.uk.

801085744

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PharmacoEconomics & Outcomes News 19 Oct 2013 No. 6891173-5503/13/0689-0001/$14.95 Adis © 2013 Springer International Publishing AG. All rights reserved