Pharmaceutical Commerce - May/June 2017 - 17
Market Access important part of our responsibility is to help them understand what they have seen or read, and its possible relevance to their treatment options." Another I/O modality that is different from checkpoint inhibition is the use of modified T cells (CAR-T)-which thus far has no approved therapies yet, but is eagerly anticipated as regulatory approval of the leading candidate is expected in the near future. "This modality is generating significant interest and excitement from all stakeholders as CAR-Ts have shown activity in relapsed lymphomas, acute lymphoblastic leukemias, and chronic lymphocytic leukemia," say Nabhan of Cardinal Health. However, he notes that "the toxicity of CAR-Ts can be severe and careful attention to how these adverse events should be managed is essential to assure favorable outcomes to patients." Will competition moderate costs? Worldwide spending on cancer medicines will exceed $150 billion by 2020, up from $107 billion in 2015 according to recent data from IMS. "Cost is clearly the most pressing issue associated with I/O therapies, and stakeholders agree that manufacturers need to demonstrate the value of this modality in a changing reimbursement landscape where cost containment and maximizing efficacy is a paramount concern to payers," says Nabhan of Cardinal Health. "The best way to position a new agent among its competitors and maximize payer coverage is to know which patients are most likely to receive response with the agent, and then gearing studies toward that population. This requires good science and thoughtful trial design, and is certainly one of the main challenges facing the I/O community over the next decade," says Cowey of Texas Oncology. Today, cancer researchers are pursuing both traditional and non-traditional biomarkers, including "tumor neoantigen profiling," "mutational load analysis," and identifying certain infiltrating immune cells within tumors, to improve the deployment of checkpoint inhibitors. "Combining checkpoint inhibitors with older or generic chemotherapy may not drive up costs as dramatically, but once you combine two immune therapies, with a biologic or a newer non-biologic specialty drug-so-called stacking-that's going to create enormous cost issues," adds Evans of Genentech. Clearly the argument can be made that using a combination of therapies in search of the most advantageous synergistic effects to drastically improve outcomes represents money well spent, to get the patient into remission or even cured and back into their productive lives, where they are living longer lives, supporting their families and so on. Many believe that there will always be a tipping point where really effective treatment-or even cures-can help justify huge price tags. But it helps to back up such claims with real-world evidence. "Consider the use of Yervoy and Opdivo in combination to treat melanoma- the cost can easily run to $200,000. While Bristol-Myers Squibb is offering a discount for patients who use both therapies simultaneously, it's important to note that the costs aren't necessarily hitting the patients-they are falling on the backs of the payers and the drug companies, who shoulder much of the high cost," says Sanchez of Trinity Consultants. That's why there's keen interest in making sure only the right patients are getting these costly therapy options, and helping to manage the affordability. "Drug makers do not want to risk headlines of patients abandoning promising therapy options because of the cost, so RWE data (which is always messy due to poor adherence and tolerability issues) must be developed to drive the most appropriate utilization." Despite the hurdles, some expect growing competition in I/O to help keep costs down. "We now have a lot of different I/O products being pursued. This is already seeming to bend the cost curve for new drugs developed under the bio umbrella, where we may be seeing a 10% price premium, over traditional therapy options-not a 25% price premium," says Sanchez. "As multiple I/O drugs are racing to the finish line, the competition should favorably impact the starting costs that were common just a few years ago." One promising combination is the use of ADCs (to shrink or "de-bulk" the tumor and prime the immune system) in conjunction with I/O therapies. "When the promise of this combination is realized, then the length and quality of life that patients might achieve should justify that cost," says Gregory of ImmunoGen. More than ever, reimbursement is contingent on showing value of a particular therapy where value is broadly defined as outcomes divided by cost. "RWE studies and patient-reported outcomes that can show how efficacy and quality of life are potentially improved for patients when I/O therapies are administered and used under real-world conditions are becoming essential in payers' determination of favorable coverage," adds Nabhan of Cardinal Health. "Due to the high cost of immunotherapies, manufacturers need to proactively engage payers and other stakeholders early on in cost-effective discussions and leverage various value frameworks to communicate a comprehensive value story of these innovative therapies," says Shields of Xcenda. "Similarly, patients may face exorbitant outof-pocket costs, so in addition to traditional foundation programs, it will be imperative for pharma companies to establish farreaching patient-assistance programs (PAPs) that can help to offset those costs." Value frameworks "Oncologists are already overwhelmed. Avella pitches specialty pharmacy's benefits in managing cancer care Less drug waste, fewer ER visits can offset high drug costs For years, some observers have called the trend in cancer therapy "unsustainable" as cancer cases rise, and the number-and cost-of drug therapies rise even faster. In a just-released white paper, Avella Specialty Pharmacy doesn't address these trends directly, but does offer that specialty pharmacies like itself can moderate rising healthcare costs. The paper's argument, based largely on existing studies, positions specialty pharmacies as a key member of the care team: payer, physician and patient. On a per-member, per-month basis, cancer care has risen from 9.4% of overall cost for commercial plans in 2004, to 10.7% (most analyses expect this proportion to jump higher in the next few years). Oncology drug sales have nearly doubled from $28 billion in 2008 to $50 billion in 2016, and are on pace to reach $75 billion in 2024, according to cited Datamonitor Healthcare statistics. And in 2016, while there were 21 oncology drugs approved by FDA, 12 were oral oncolytics-and therein lies the patient-support problem, since oral products are typically consumed at home by the patient (and are often dispensed from specialty pharmacies). Adherence for such therapies is sub-optimal; it dropped, in one study, from 91% during a clinical trial, to 56% when the drug was commercialized. Two prime reasons for non-adherence are drug cost and unmanaged side effects. To address these, Avella touts its role in helping patients obtain financial assistance (claiming $54 million in such support during 2016), and patient support through education and such tools as starter kits containing OTC products to address side effects. It also provides treatment data back to healthcare providers and payers, and looks toward integrating its data resources with the electronic medical record (EMR) systems at health facilities for a higher level of care coordination. The free white paper is available at Avella's website at https://info.avella.com/outlook-oncology-whitepaper. May | June 2017 Visit our website at www.PharmaceuticalCommerce.com 17
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