By Ciaran Cassidy, Snr Analyst
On the 25th of July, the AEMPS of Spain published the first Therapeutic Positioning Report (Informe de Posicionamiento Terapéutico, IPT) including both a clinical and a cost-effectiveness assessment.1
The Coordination Group of the National Health System (NHS) Drug Evaluation Network (REvalMED) evaluated Pfizer’s Talzenna® (talazoparib) as monotherapy for pre-treated HER2-negative locally advanced or metastatic breast cancer with germline BRCA 1/2 mutations.
REvalMED conducted a cost-effectiveness assessment of Pfizer’s Talzenna®
The methodology applied to the economic evaluation was defined last year when the Ministry of Health announced changes in the way IPTs would be developed to include economic elements. This methodology includes a cost-utility analysis (measured in quality-adjusted life-years, QALYs), incremental cost-effectiveness ratio (ICER), and a budget impact analysis2.
The cost-effectiveness analysis was conducted via an indirect treatment comparison between phase III data for Talzenna® and Lynparza® (olaparib), which is currently funded for the treatment of ovarian cancer. Lynparza® was chosen as a relevant comparator because Talzenna® could not compete in cost-effectiveness with a physician’s choice therapy (capecitabine) in earlier line patients. As Talzenna® did not have a Spanish price at the time of the analysis hypothetical prices of 85% and 65% of Lynparza’s® price were used.
While the IPT does not state the final decision, Talzenna® demonstrated an improved progression-free survival (over physician-selected treatment but not Lynparza®). However, this was not found to demonstrate a benefit in overall survival nor a sufficient benefit in quality of life versus physician-selected treatment or Lynparza®. It is also worthy for manufacturers to note that the use of a biomarker does not in itself lead to therapeutic advantage over existing treatments, and that total healthcare costs associated with Talzenna® in the NHS were used.
The new cost-effectiveness process is expected to reduce time taken to produce IPTS
While indirect treatment comparisons are possible, manufacturers will have to provide additional information in order to support the health economic evaluations. This will include acquisition price, dosing, cost per day/cycle, cost of full treatment or treatment per year amongst other data3.
This new process is expected to significantly reduce the time required to produce IPTs. A recent analysis found that IPTs took 265 days to produce on average, a consequence of this is more than 33,000 requests for compassionate use of medicines each year in Spain4. The General Director of the Common Portfolio of Services of the National Health and Pharmacy System, Patricia Lacruz, suggested that the inclusion of health economic evaluation in the new process will streamline the pricing and reimbursement process for the CIPM. This change should also expedite access to new drugs4,5.
Although the inclusion of a health economic component in the Spanish HTA presents an opportunity for Spain to expedite access to new drugs and make for more efficient healthcare spending, it is unclear how this will affect the access to orphan drugs and curative therapies. The new process includes seven evaluation “nodes” divided into therapeutic areas, one of which is rare diseases and advanced therapy medicinal products (ATMPs), so there does appear to be special consideration for these therapies. A pilot IPT is planned for each of the therapeutic areas this year, which could more accurately demonstrate how receptive REvalMED is to measuring the cost-effectiveness of orphan or curative therapies.
Moving forward this new process could require further considerations from ATMP manufactures
Moving forward, one key consideration for manufacturers looking to launch gene therapies in Spain, besides the challenges associated with a gene therapy’s cost-effectiveness (e.g. long-term data uncertainty and the sample size of clinical trials), is that the budget impact will also form key parts of the assessment. Therefore, even if a manufacturer is confident in their curative therapy proving cost-effective over the long term, they may also have to consider how to help towards a manageable budget impact in the short term.
As we progress through the year manufacturers should monitor the outcomes and special considerations for the assessment of orphan drugs and ATMPs. It will also be important to observe any moves towards innovative access agreements to manage uncertainty and budget impact of curative therapies with long-term efficacy.
Overall Spain’s move to include health economic assessments as part of their HTA process might shift the market archetype from a purely budget impact market to a cost-effectiveness market. Due to this, manufacturers will need to change their market access considerations of Spain, the feasibility of innovative access agreements, as well as where Spain might sit in their go-to-market strategy and launch sequence.