BPJ special edition - Generics
Full colour PDF of the pages as they appeared in ‘best practice’.
Printer friendly PDF.Contributed by Dr Dilky Rasiah, PHARMAC
How does PHARMAC assess if a brand change is appropriate?
PHARMAC carefully considers whether brand changes for specific medicines are appropriate, taking into account clinical risks. Clinical risks are particularly important where there are limited treatment options within the therapeutic group, where the medicine has a narrow therapeutic index, or where patient adherence is considered critical and could be compromised by the brand change. PHARMAC does not usually consider these types of medicines for sole supply.
Over the years PHARMAC have learnt a considerable amount about what the trigger factors are for negative reactions to brand changes. This may lead to a medicine not being tendered or, if tendered, an increased focus on implementing the change. Trigger factors include:
- Does the medicine have a large patient population (over 50,000 patients)?
- Is the current brand well-known with high brand loyalty (e.g. Ventolin, Panadol, Losec)?
- Is the medicine heavily marketed to patients and doctors?
- Does the new brand have a different colour, shape or taste?
- Is the medicine primarily used by children, or elderly people?
- Has there been negative feedback to consultation, or political lobbying around the change?
In addition to careful internal deliberation, PHARMAC takes advice on brand change options from clinicians and pharmacists. This includes seeking advice from PHARMAC’s standing clinical committees and consulting with healthcare professionals more widely.
PHARMAC only seeks to implement brand changes if the new brand is approved by Medsafe. Although not the norm, PHARMAC sometimes awards tenders subject to Medsafe-approval being achieved.
Advice from clinicians
PHARMAC drafts an annual “invitation to tender” containing numerous medicines and then seeks feedback on a draft tender list from medical groups, clinicians, pharmaceutical companies, DHBs and other interested parties. Comments from consulted parties, typically relating to potential clinical concerns for sole supply for any of the medicines on the tender list, are taken to PHARMAC’s Tender Medical Evaluation Subcommittee for comment. This committee of doctors and pharmacists provides advice on all issues related to tendering medicines, including switching brands.
The Tender Medical Evaluation Subcommittee may also seek further advice from other PTAC subcommittees specialising in therapeutic areas.
Other purchasing methods
Should a medicine not be included in the tender, other methods can be used, including (a) Dual supply – this is used for the influenza vaccine; (b) Listing multiple brands with reference pricing – this is used for the asthma inhaler salbutamol; (c) Ongoing contracting with incumbent supplier – sometimes necessary to maintain patient health and compliance, but has risks if suppliers wish to increase prices; and (d) Special Access by authorisation – this is currently being used for the ADHD treatment Ritalin; however PHARMAC has identified adherence issues that make this scheme difficult to manage.
No matter how much advice is sought, brand changes often come down to a judgement call about the level of potential benefits versus the potential costs and risks. Should a change in pill colour, or a bigger pill, be avoided and forego significant savings? This is the typical dilemma PHARMAC faces, and savings can be in the millions of dollars for each medicine. Even if a brand change is considered to pose issues with acceptance, effective education and implementation strategies may still allow the brand to be changed.
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Comments recieved about this article
Comment from:
Patrick Crisp
Comment from:
Dave Woods
Here is the response from Medsafe re. Your question.
Medsafe and medicines regulators in Europe and Australia were made aware of the FDA inspection findings in October last year. Ranbaxy's manufacturing process was not found to be deficient, the FDA called into question the final testing of manufactured product made at two Ranbaxy sites, their subsequent action related to product that was manufactured at a single site in Paonta Sahib. As a result of the information provided by the FDA the two manufacturing sites in question underwent a number of independent inspections. The inspections were both announced and unannounced and were undertaken by an International inspection team over three months at the end of last year. The inspection team included inspectors from Australia, Europe and the World Health Organisation. The results of these inspections revealed no evidence of fraud or any reason to suspect that the quality of the medicines that are manufactured by Ranbaxy did not meet the high standards required. Based on the inspections the TGA in Australia, and European Medicines Agency representing the 28 European member states did not find any reason to follow the action taken by the FDA. In addition, pending the results of the inspections Medsafe contacted the New Zealand sponsor for the relevant medicines who voluntarily impounded the product. The medicines in question also underwent independent testing, commissioned by Medsafe which revealed no issues relating to the quality of the medicines produced by Ranbaxy. It is also important to note that the FDA action did not result in a recall of any Ranbaxy product from the US market and indeed the FDA are still allowing the import of one product that is produced at the site in question. having examined all the evidence Medsafe had no reason to believe that regulatory action was necessary. The bioequivalence testing of products produced by Ranabaxy has not been questioned by the FDA and product manufactured by Ranbaxy at sites other than the Paonta Sahib plant are still allowed to be imported and used in the US. Medsafe is committed to ensuring the quality, safety and efficacy of all medicines in New Zealand.
For more information see;
http://apps.who.int/prequal/info_press/Ranbaxy_samples.pdf
Thanks
Kind regards
Enver Yousuf
Manager, Product Regulation Branch
Legislation Review
Medsafe