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Find out about the latest treatment and drug pipeline developments
Cancer and diabetes remain top therapeutic areas for healthcare executives to watch in 2017, but other conditions, such as autoimmune diseases, fatty liver disease and the rarer Duchenne muscular dystrophy are sparking interest in the upcoming year.
With an explosion of new and combination specialty and other drugs, these areas are ripe for grabbing the attention of managed healthcare. The projected specialty/biotech trend rate for 2017 is 18.7%, according to Segal Consulting.
“Specialty drugs are the largest driver for all areas,” says Carmelina Rivera, practice leader, West Division Pharmacy, Willis Towers Watson. “It’s where we will feel the most pain, and they will continue to be a problem.”
Here are some of the latest developments in top therapeutic areas for 2017.
Heather Morel, chief operating officer, The US Oncology Network, says oncology is a key therapeutic area no matter which way you slice it. She attributes the focus to an aging population-a cohort that cancer is most likely to affect-advances in treatment, early detection, patients living longer and more multi-modal therapies, including surgery, radiation and medication therapies. She says, however, that the biggest cost contributor is hospital care.
Immunotherapy, a treatment designed to help the body naturally fight cancer, is the big thing in oncology right now-a trend continuing from last year, says Julie Rubin, director of clinical services, CompleteRx, a pharmacy management company. Biologic therapies like nivolumab (Opdivo) and pembrolizumab (Keytruda), commonly referred to in practice as “checkpoint inhibitors” are recent examples of drugs designed specifically for this purpose.
Immunotherapy is an expensive, incredibly novel set of treatments that have a great impact on survival, Morel adds, pointing out its six indications: non-small cell lung cancer, renal cell carcinoma, melanoma, Hodgkin’s lymphoma, head and neck cancer and urethral cancer (bladder cancer).
“Historically, if you had breast cancer, we treated you for breast cancer, but now we’re going way beyond that looking at how all of the immune pathways work and how drugs can be used to manipulate those pathways to therapeutic advantage. We’re developing biomarkers that allow us to identify patients who will be most likely to respond well to immunotherapies,” Rubin says. “Not all cancers look alike so there are going to be more granular options.”
Next, she says, it’s expected that the FDA will approve immune checkpoint inhibitors as a first-line therapy for more cancer types, which should have a huge impact on disease spread and growth. These inhibitors have been approved only as a second-line therapy for advanced lung and kidney cancers that have not responded to other therapies and as a first-line therapy for advanced, unresectable melanoma, she adds.
David Lassen, chief clinical officer for Prime Therapeutics, a pharmacy benefits manager, says there is a “rich pipeline” for oncology drugs with unique mechanisms of action and an organic expansion of new indications for existing drugs. He says oral cancer drugs consume 5% of the PBM’s drug costs.
Up until recently, treatment for bladder cancer has remained the same for decades. Nivolumab received a breakthrough therapy designation in June 2016 and is expected to be approved in March of 2017 for the condition. It already received the designation for previously treated non-small cell lung cancer, advanced melanoma and metastatic cell carcinoma.
Rivera at Willis Towers Watson says oncology is growing because many new and existing drugs are targeting specific cancers. “Many manufacturers seek one indication to get a drug on the market but once in use, provide evidence of value for other indications,” she says.
She warns payers and PBMs that they should evaluate pathways to ensure drugs are being used for the right indications. “Pathways drive evidence-based ways to treat patients,” she says.
Tecentriq (atezolizumab) is another recently approved drug for bladder cancer and is due to hit the marketplace in late 2017 or early 2018. Its price tag will be about $12,500 a month, or about the same as Opdivo.
Two generics for Gleevec (imatinib mesylate) that treats myelogenous leukemia joined the market in 2016. The cost of brand Gleevec since its approval in 2001 has quadrupled. In anticipation of patent expiry, the average wholesale price (AWP) of Gleevec jumped 45% from January of 2014 ($102,000 per year) to $148,000 per year today, per Medi-Span database figures.
And in October 2016, the FDA approved Keytruda as a first-line therapy for non-small cell lung cancer, making this the first-time immunotherapy has been designated as an initial treatment for lung cancer.
Another important drug is Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. “The approval constitutes the first of a new class of drugs for treating ovarian cancer,” Morel says.
In addition, Mylan N.V, and Biocon Ltd. submitted a biologics license application for a proposed trastuzumab biosimilar to Roche’s Herceptin treating certain HER2-positive breast and gastric cancers.
Lassen at Prime Therapeutics calls diabetes the number one nonspecialty drug category, accounting for 13% of the PBM’s total drug spend.
“The majority of that increase is due to more utilization and inflation,” he says, “but also to new, higher cost brands that are being promoted-an average cost of $300 a month for a combination of oral and injectables compared to $20 for a generic. We want to better understand the data to determine if the much higher costs justify incremental improvement in overall treatment.”
Some injectibles might be more convenient because they only need to be taken once or twice a week vs. daily oral medications. “But do they improve outcomes?” he asks.
There is currently no generic insulin available for diabetes.
Rubin sees diabetes as ripe for advancements in treatment, starting with less stringent warnings from the FDA on using metformin, which is a first-line medication prescribed for type 2 diabetes.
In December 2015, the FDA approved Basaglar (insulin glargine injection) as a follow-on product to Lantus for treating types 1 and 2 diabetes. Basaglar is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. It became available in December 2016.
Chris Peterson, director of emerging therapeutics for Express Scripts, says Basaglar should help bring down the cost of Lantus, providing a negotiation tool with manufacturers.
Xultophy, a combination of two existing drugs-Victoza (liraglutide), a glucagon-like peptide-1 receptor agonist, and basal insulin Tresiba (insulin degludec), was approved in November 2016. Soliqua 100/33, a combination of Lantus and lixisenatide, was also approved in November. Regardless of price, the once-a-day administration for both might make the drugs more palatable.
Prime Therapeutics has found that specialty drug spend for autoimmune drugs doubled between 2012 and 2015, accounting for 10% of drug expenses for 4.4 million commercially insured members.
Biopharmaceutical companies have 311 medicines and vaccines for
in clinical trials or awaiting review by the FDA according to the Lupus Foundation of America’s “Medicines in Development 2016 Report.” They target conditions, such as Crohn’s disease, psoriasis and rheumatoid arthritis.
Rivera says autoimmune diseases were a concern in 2016 and are expected to continue to be on payers’ radar-especially with the introduction of biosimilars treating conditions in this category.
The FDA approved Inflectra (infliximab), which is a biosimilar to Remicade for Crohn’s disease, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis April 2016; it is expected to be on the market in November. The biosimilar should sell for 15% less than the originator drug-$946 vs. $1,113 a vial, respectively-according to Truven Health Analytics.
Biosimilar alternatives to Humira (adalimumab) and Enbrel (etanercept), two anti-inflammatory drugs for rheumatoid arthritis, are headed to the market, but the originator manufacturers-AbbVie and Amgen, respectively-are trying to push new patents to prevent them from coming on board. The FDA approved Sandoz’s new product for Enbrel, called Erelzi (etanercept-szzs), in August 2016 and the one for Amgen’s Humira-Amjevita (adalimumab-atto)-in September 2016.
Rivera is concerned that a lack of familiarity with and information about biosimilars might deter physician prescribing. “Many physicians are brand loyal and might not be comfortable with interchangeability,” she says, “driving up costs.”
Rivera anticipates that biosimilars could bring additional competition that might bring the cost down by as much as 30%. “We will be able to deploy care management principles, such as formulary-what’s covered, what’s excluded-to drive manufacturer rebates,” she says.
Rubin says executives should keep an eye on new drugs coming to market, evaluating their formularies to keep costs down and hopefully keep patients more compliant and in remission for longer in 2017.
Robert Goldberg, vice president, Center for Medicine in the Public Interest, agrees that 2017 will yield more drugs regulating rare autoimmune disorders such as Lupuzor, the first specific and non-immunosuppressant therapy for lupus; however, it has not yet been approved.
The FDA also has approved seletalisib, a potent and selective small molecule inhibitor of PI3K delta for the treatment of immunodeficiency disorders.
“These drugs are examples of first-in-class medicines for orphan diseases that also have fewer side effects,” Goldberg says. “Payers that limit or delay access to such medicines may find themselves facing lawsuits from patient groups.”
Payers have to move away from formularies based on how much rebate revenue they can get and focus on finding out what works for each patient, he says. “Similarly, payers will have to shift away from step therapy in which patients are required to start on one drug and see if they respond. The fact is, step therapy actually risks patient well-being. Requiring a treatment because it's cheapest or generates the most rebate often leads to inappropriate treatment and in turn, organ damage or more severe illness.”
In addition, Goldberg says, “The most effective drug is the one that works and that patients continue to take. So again, payers should focus on adherence rather than the drug itself.”
Treatments for rheumatoid arthritis and multiple sclerosis have generally been effective at reducing disease fueling inflammation, but have been limited to treating the symptoms of the disease, allowing for a steady, rapid progression from disease onset to disability, Goldberg says. Biologic disease-modifying drugs target the underlying sources of inflammation and re-establish balance in a cell's immune system. So these drugs improve physical well-being and promote repair of joint and organ damage and remission.
That means new medicines are not interchangeable with older drugs, nor are they interchangeable with each other; however, often they can be used in combination to target various drivers of illness, Goldberg says.
Another new area of interest is NASH (nonalcoholic steatohepatitis), or fatty liver disease. In May 2016, the FDA approved Ocaliva (obeticholic acid) in combination with ursodeoxycholic acid. Its cost is expected to be about $69,350 per year, according to Intercept.
Lassen says despite its price tag, the new drug could be a gamechanger.
Finally, two new drugs for atopic dermatitis are expected at the end of March 2017; the unnamed drugs are both forms of dupilumab. They are biologic injections with no other competition.
At press time, Ocrevus (ocrelizumab) for multiple sclerosis was expected to appear on the market by late December 2016, along with other competitors in 2018, Rivera says.
And finally, Taltz (ixekizumab) was approved in March 2016 for psoriasis.
The high cost of two drugs called PCSK9s introduced in 2015 for significantly lowering LDL cholesterol-Repatha (evolocumab) and Prauluent (alirocumab)-have forced some payers to deny members access because of the drugs’ more than $14,000 a year price tags; however, the medications have proved to perform as promised.
“Healthcare executives should proactively develop guidelines to determine who can qualify for these agents. For example, adults with heterozygous familial hypercholesterolemia, an inherited condition that causes high levels of LDL cholesterol in the blood, might be good candidates, as they see a larger risk reduction following treatment than other patients,” Rubin says.
Andrew Lyle, director of business development for Curexa, a compounding and specialty pharmacy, says the two drugs have difficulty gaining approval from payers and are expensive. “Doctors are trying to write prescriptions for them but they require prior authorization and other step therapies. And they don’t make any sense if members are not compliant.”
The therapeutic area of hepatitis C calmed down after the 2013 approval of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) in 2014, but in June 2016, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first single tablet regimen approved for treatment of all genotypes of the virus, was approved.
Lyle says, however, that it should cost less than the initial prices of its predecessors, about $890 per pill versus $1,000 and $1,125 for Sovaldi and Harvoni, respectively. In addition, in January 2016, Zepatier (elbasvir and grazoprevir) to treat genotypes 1 and 4 in competition with Harvoni came on board costing $54,600 compared to Harvoni’s initial price of $94,500 for a course of treatment.
CareMark will cover Harvoni, Sovaldi and Epclusa and has removed Viekira Pak from its formulary, while Express Scripts remains loyal to Viekira Pak.
Aimee Tharaldson, senior clinical consultant, emerging therapeutics for Express Scripts, says that although there has been a lot of attention paid to cancer drugs, there has been even more directed at orphan drugs. Cancer drugs (non-orphan status) account for 22% of the specialty drug pipeline, while orphan drugs account for 40%, she says. In addition, 30% of these drugs are expected to be blockbusters. Tharaldson shared this information as a keynote speaker at the Academy of Managed Care Pharmacy 2016 Nexus conference.
Medications for some orphan diseases are moving through the pipeline, such as the first treatment for Duchenne muscular dystrophy (DMD) called Exondys 51 (eteplirsen) that received accelerated approval in September 2016, and corticosteroid deflazacort, also for DMD, awaits further study.
Two new drugs for tardive dyskinesia, involuntary movements of the face and jaw, could be on the market in 2017-valbenazine and deutetrabenazine. Neurocrine Biosciences submitted a New Drug Application for the first in August 2016, while Teva received breakthrough therapy designation status in 2015.
Other new drugs are targeting more common chronic diseases. The FDA approved Bevespi Aerosphere, a combination of glycopyrrolate and formoterol fumarate, to treat chronic obstructive pulmonary disease, in April 2016. The product with its new co-suspension technology, which helps maintain consistent dosing for a combination of drugs in a single inhaler, competes with two other dual bronchodilators already on the market.
Mari Edlin, a frequent contributor to Managed Healthcare Executive, is based in Sonoma, California.