Information for Payers
The systems and processes in place for reimbursement for medicines differ from country to country. However it is generally recognized that health service decision makers and budget holders need to be aware of new drug launches and their potential impact on budgets (nationally and locally) some time in advance.
It is important that such information is only directed to those responsible for making policy and budgetary decisions, and not to potential future prescribers of the product.
Here are some examples of where provision of such information may occur – click on each for more information:
- HTA (health technology appraisal) submissions
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These are made to national bodies regarding the clinical and cost effectiveness data for a product which may be pending a marketing authorization
- Advanced notification to budget holders
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This is usually a local and regional activity – information is provided to budget holders about the planned launch of a product which may not yet be licensed, in order to assist them with their budget planning. This is usually only considered acceptable if the launch is likely to have a significant impact on health service budgets (either additional costs or cost saving). The information should state what the likely impact is and should not contain product claims or statements about the product which are not relevant to its budget impact
- Horizon scanning
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In some countries the health service authorities expect companies to provide information on pipeline products as part of their ‘horizon scanning’ processes. This may be forward looking by several years, to ensure there are no ‘surprises’ in terms of health service provision and budgeting.
Advance budgetary notification
In the UK Pfizer complained about a Daiichi-Sankyo satellite symposium held at the Pharmacy Management National Forum, entitled ‘Financial and Policy Planning in Partnership with the NHS - A New Oral Treatment for the prevention of stroke in atrial fibrillation (AF) and treatment and secondary prevention of venous thromboembolism (VTE) in 2015 - Advance Budgetary Notification’
The new oral treatment at issue was edoxaban, an anticoagulant that was expected to be available 6 weeks after the symposium.
The symposium was advertised along with a synopsis on the Forum’s website which was publicly accessible. Pfizer said that this was promoting edoxaban before the granting of a marketing authorisation.
To register for the symposium delegates had to self-certify that advance budgetary notification content was relevant and appropriate to their role. Pfizer was concerned about the group nature of the advance budgetary notification because attendees would be from across the UK. The advance budgetary notification discussion should be about the significant budgetary impact locally for a payer. Everyone’s budget would be impacted differently. Pfizer also questioned whether there was adequate time to influence the budget with only 6 weeks notice.
On investigation the Authority found out that each satellite symposium lasted 40 minutes. The first 20 minutes consisted of two presentations; one from the regional business director (10 minutes) and one from a medical science liaison representative (MSL) for 10 minutes. Together the two speakers had 38 slides. The final 20 minutes of the symposium was for 1:1 individualised discussion around the local budget impact using a cost model.
Which of the following statement do you agree with:
- The publication of the synopsis on an open access website would constitute pre-licence promotion
- 6 weeks notice of a new launch is too short for payers
- Self certification of a payer role to gain entry may not be sufficient
- The widespread notification of the meeting is not approvable
- Using a symposium for advance notification is completely unacceptable
Ruling
The Panel considered that the notification and synopsis on the open access website constituted pre-licence promotion. They were critical of a symposium as a means to carry out advance notification and stated that the 20 minute time for a 1:1 discussion was unlikely to be enough for a delegate to fully understand the impact on their own budgets. They ruled that the company had brought discredit to the industry (that this was a very serious breach of the rules).
On appeal the ruling of pre-licence promotion was upheld. However he Appeal Board considered that the arrangements for ensuring that only payers attended the symposium were sufficient and that the company had not brought discredit to the industry.
