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Partnering in healthcare seems to be the prevailing wind while achieving access, cost effectiveness, and high quality remains the aim of the industry.
Partnering in healthcare seems to be the prevailing wind while achieving access, cost effectiveness, and high quality remains the aim of the industry. It is evident in accountable care organizations, in hospitals buying up physician groups, and large pharmaceutical companies acquiring smaller ones.
Now a unique alliance is evolving between pharmaceutical companies and insurers, helping manufacturers guide drug development based on input and data from health plans.
US payers want more involvement in every stage of the drug development process, according to Quintiles, a biopharmaceutical services company in Research Triangle Park, N.C. Its New Health 2012 Report indicated more than 70% of survey respondents-US and UK payers and biopharma executives-believe that pre-competitive collaborations among biopharmaceutical companies would lead to more innovative and effective therapies. Only 31% of US payers, however, claim to participate in phase 3 testing.
“In the last 5 years, meeting the needs of health plans has become front and center as we focus on the unsustainability of healthcare, and see a shift from volume to value,” said Jack Bailey, senior vice president, policy, payers, and vaccines for GlaxoSmithKline (GSK), also in Research Triangle Park, N.C. “We have to deliver products of value to customers who are paying for drugs in addition to developing drugs based on clinical and safety regulations. Pharma needs rewiring, a new process that allows payers to provide feedback early on that could ensure trials are designed with payers in mind, and help us achieve a ‘reimbursable file.’”
Bailey outlined 3 payer priorities GSK factors into the development of its pipeline:
1. Develop a relevant comparison between drugs, when possible, not just against a placebo.
2. Create a meaningful clinical endpoint to assess a drug’s performance. “That is the most compelling to payers in determining a drug’s coverage on formulary,” Bailey said.
3. Identify an appropriate target population for a drug to confirm its effectiveness.
It’s not just a question of research and development but also commercialization of a drug product.
“There is a definite wall between the two, but integration of strategies is necessary. If we are unsure that we can provide sufficient clinical evidence and support reimbursement, we may have to redesign a drug,” Bailey said.
He said GSK goes so far as to listen to payers to determine if developing a specific drug makes sense. For example, in 2009 GSK stopped its development of remogliflozin, an SGLT2 inhibitor for treating type 2 diabetes, when it was in phase 2 testing, based on feedback from payers and the company’s assessment of the competitive environment.
Brian Solow, MD, chief medical officer, OptumRx, a pharmacy benefits manager (PBM) in Irvine, Calif., agreed that health plan involvement in drug development is a relatively new phenomenon. “As a PBM, we could only offer input after a drug was already developed and gone to market,” he said, “but in the last 5 years, there has been a shift. Now pharma is coming to us to obtain input at phase 2 or phase 3.”
He said communication is not based so much on needs-manufacturers typically know what payers want-but rather on what a manufacturer can do to make its drugs more attractive so that PBMs will recommend those drugs for plan formularies.
Using Real-World Evidence
Edmund J. Pezalla, MD, national medical director, pharmacy policy and strategy for Aetna, sees a change in the way drug manufacturers are cooperating with payers. “Most marketing input occurs right before approval and is tied to reimbursement considerations,” he said. “But now companies are backing up to phase 3 and asking us what we would like to know about a drug, while providing outcomes and end points, a drug’s effect on quality of life, and results using a control rather than a placebo.”
He said they are listening to Aetna’s opinions about whether a drug should be covered under the pharmacy or medical side, how the drug could potentially perform in the marketplace, and where the drug might fall on formulary in conjunction with current therapies. Manufacturers are not, however, asking health plans whether they should develop a certain drug, he said.
Like his colleagues, Dr Pezalla said that real-world evidence and data are key to relationships between payers and pharma. Most of Aetna’s available data, he said, is administrative and claims information rather than clinical. Nonetheless, he anticipated that the insurer will be able to provide additional information through the use of electronic medical records, enhanced relationships with providers and through participation in accountable care organizations.
Dr Pezalla pointed out that pharma faces 2 major hurdles-meeting regulation standards for FDA and getting a product to market. “You can’t do the latter if no market exists,” he said. “It no longer works to just be guided by science, but you also need to assess how drugs are used, their quality, cost, effectiveness, and safety.”
Taking the Right Steps
John J. Doyle, senior vice president and managing director, global market access and commercialization for Quintiles, said pharmaceutical companies must engage payers to develop a value story, optimal price, and reimburseability.
He believes that communication should start as early as phase 1 and 2 of clinical trials. “Payers want to know how decisions to develop a certain drug are made. To be successful, drug companies must look at the pharmaceutical landscape-what is already on the market and how they can fill gaps-consider reimbursement issues and determine how the drug can help patients,” Doyle said.
The next steps are describing the drug profile (its clinical, safety, efficacy, and humanistic benefits), weighing potentially higher costs against value propositions (such as fewer side effects, a decrease in hospital and office visits, and fewer hospital readmissions), and testing new products against the competition and standards of care.
“Once the data set is available, manufacturers should determine the level of evidence payers require to move the needle toward a favorable decision,” Doyle said. “Payers want to know how a drug performs beyond a randomized control trial; they need a drug to demonstrate its value in a population specific to their membership and provide real-world evidence that validates trial findings-more outcome metrics than FDA requires.” â