Amid the din of drug-pricing tussles, rapid scientific advancements are nurturing individualized anticancer approaches and sharpening the view of cancer’s underlying biology
Science-wise, the oncology sector has been hitting it out of the park with solutions promising improved survival with lower toxicity for some patients. Alas, it’s not all about the science: Biopharmaceutical companies with a large presence in the sector are getting snared in widespread pricing complaints, overwhelming data hurdles, and climbing development costs.
The global oncology market is riding a steady growth trajectory, with little sign of stopping. Oncology drug spend soared to $107 billion worldwide in 2015 and is projected to reach $150 billion by 2020, according to figures from IMS Health.
The march away from short-term cytotoxic treatments to embrace long-term care has ushered in a new phase of immuno-oncology and combination therapies. For some patients, immunotherapies promise improved survival with lower toxicity. Indeed, in aiming to address multiple pathways in a tumor, combination therapies could lead to substantial increases in survival.
Immunotherapies like Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have come out on top. The PD-1 inhibitors, approved to treat several types of cancer, have single-handedly shaken up the oncology market. “Immunotherapies are one of the most important cancer research advances in decades,” says Dr. Dietmar Berger, senior VP, global head of clinical development, hematology and oncology at Genentech.
Although the possibility that immunotherapies (including CAR T-cell therapy) can knock out some cancers for good is becoming more and more real, two challenges might prove insurmountable. Critics point to safety concerns in early clinical studies and to the sky-high development costs due to the therapies’ highly individualized nature.
“There’s a tendency to look at the lab bench rather than the market,” says Gil Bashe, managing partner, Finn Partners. “In oncology, the market also represents pipeline potential.”
See also: Top 25 oncology products in 2015
Marketed cancer products are increasingly meeting safety and efficacy standards in second and third indications. Bristol-Myers Squibb’s pair of market leaders, Yervoy and Opdivo, have their sights set on lung and kidney cancer. “Skin cancer is only the beginning for these blockbuster immunotherapies,” Bashe notes.
Discovery USA’s associate scientific director, Dr. Scott Salsman, says oncology’s biggest promise lies in the technological advancements of already-successful approaches. “We’re glimpsing second-generation therapies of PD-1, PD-L1, and CTLA-4 checkpoint inhibitors, and CDK4/6 and PARP inhibitors,” he explains. “There’s good reason for pharma’s continued investments in these categories.”
Adds Berger: “Now we’re at a point where we’re seeing FDA approvals [of immunotherapies] in other cancers.” To that end, Roche’s Tecentriq (atezolizumab), recently approved for advanced bladder cancer and already in the hunt for additional indications, is the third PD-1/PD-L1 inhibitor to hit the market.
THE HUNT CONTINUES
To keep pipelines stacked, big biopharma continues to compete for highly advanced assets from smaller, nimbler firms. The hottest target of 2016? Medivation, for its blockbuster treatment Xtandi and solid pipeline. The line of potential bidders behind leader Sanofi is long, with Amgen, Gilead Sciences, AstraZeneca, Novartis, and others making inquiries.
AbbVie made a play to strengthen its oncology portfolio with a $5.8 billion deal for Stemcentrx. Although far behind in the immunotherapy field, Pfizer is plotting a climb up the cancer ladder with a trial for its triple-combination cancer agent.
Actavis filed an NDA for Celgene’s solid tumor drug Abraxane, a move expected to create market ripples in 2020. Despite the impending generic threat, Celgene ought to emerge relatively unscathed due to its significant late-stage pipeline for solid tumors and blood cancers. Either way, Credit Suisse analysts believe Celgene is poised for “best-in-class growth.”
As diagnostics gain favor, non-invasive tests such as liquid biopsies are moving up the ranks to identify patients most likely to respond to therapy without overburdening patients or healthcare systems via multiple procedures. “Liquid biopsies will positively impact precision medicine and earlier diagnosis efforts,” says Dr. Andre Goy, chairman, John Theurer Cancer Center and chief, division of lymphoma, Hackensack University Medical Center.
In June Roche’s blood-based cobas EGFR Mutation Test v2, a companion diagnostic for Genentech’s Tarceva (erlotinib), became the first FDA-approved blood-based genetic test for NSCLC-related mutations. Genomic Heath, Cynvenio, and Qiagen are also working in the liquid biopsy space. Two other players, Foundation Medicine and Guardant Health, are currently in the throes of a patent-infringement case.
Bristol-Myers Squibb spent almost $120 million more than Merck in ad spend during the year. Its DTC campaign for Opdivo launched in 2015.
VALUE AND PRICING REDUX
Biopharma companies are increasingly bogged down by drug-pricing debates. Oncology drugs in particular are facing the fire. And it’s no wonder: The cost of oncology medicines in the U.S. increased by $15.9 billion, or 72%, between 2010 and 2015, per IMS Health.
A few industry organizations — namely NCCN, ICER, and ASCO — have proposed value frameworks in efforts to gain control over the highly complex and individualized oncology drug-pricing issue. Such frameworks endeavor to make sense of the numbers and assess value based on patient outcomes in comparison to cost.
Because outcomes and cost-data change constantly, the utility of these frameworks in the real world remains unclear. “It’ll be interesting to see if any of these get adopted in the practice setting, and what influence they have on treatment decisions,” says Susan Choudhry, VP, account director at Sandbox.
Biopharma manufacturers find themselves up against a tangle of cost challenges. “They have to consider the risk to R&D programs and future investments if they decide to take a hit in the marketplace by pricing lower to keep customers happy,” Salsman explains. “But pushback against pricing can’t be ignored, as customer satisfaction is vital in any industry.”
The next layer in the ongoing oncology drug-pricing controversy relates to physician reimbursements for infused drugs. The recent CMS Medicare Part B proposal could lead to a big reduction in physician reimbursements. “Left with far more questions than answers, physicians are caught between payer push-back and patient pleas,” Bashe notes. “Biopharma innovators will have to create new payer/provider models for reimbursement.”
The pricing market may level out a bit on its own, but it could take time. “Given the number of drugs in the pipeline, the approval of multiple agents in the same category will eventually help drive down prices,” Goy says.
Digitas Health’s SVP, group account director and oncology lead Lou Iovino adds that financial toxicity is real and the days of simple parity pricing are over. “Physicians are becoming increasingly comfortable making decisions based on a drug’s clinical value versus it’s financial burden to patients and their families,” he says.
MURKY WATERS AHEAD
Interest in oncology is on the rise as the blockbuster drug era breathes its last and indications serving large patient populations fall out of favor. The convergence of trends has altered the biopharma marketing pathway in cancer care.
One of the biggest challenges is keeping up with breakthrough oncology therapies. These products — both hopeful and approved — arrive with a splash of new data, guidelines, and clinical trial information that overwhelm HCPs, patients, and caregivers.
The onus, Choudhry says, is on sales and marketing teams to share new information with HCPs in real time. “Companies are responding to this need with lightning-fast approvals of materials and more real-time tactics, like emails and digital sales tools, to deliver messages as quickly as possible,” she says.
The cost–benefit issue is theoretical for those not facing a cancer diagnosis. But for patients, knowing how to speak with an oncologist about clinical trials, immunotherapies, and genetic mutations is life or death. “Smart [drug] marketers are realizing that in-the-know patients remain a must-tap audience,” Bashe says.
That means advertising investments must be informed wise ones. Opdivo outsold Keytruda by nearly $400 million in 2015. Bristol-Myers Squibb dropped almost $120 million more than Merck in ad spend during the year. Coincidence?
A growing need to capture and analyze data from a dizzying number of streams parallels scientific advances. As genomic sequencing begins to take hold, it leaves in its wake an explosion of data about disease heterogeneity and the molecular evolution of a patient’s disease over time.
Some pharma firms look to the software powering the data. Roche recently invested in oncology software startup Flatiron Health to better inform drug research. “Real-world data can help us find and eliminate treatment patterns that might not be optimal and design clinical trials with greater probability of success,” Berger says.
The industry will witness deeper investments in collecting and analyzing patient-care data to determine what patient types — not tumor types — perform well on a certain therapy. The idea is to see how a cancer patient’s comorbidity, such as diabetes, affects the success of a particular therapy.