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Specialty medications dominate
Significant therapeutic advances that can help combat or cure life-threatening diseases have been made in the last few years. However, achieving a delicate balance between accessibility and affordability in the era of costly treatments poses a challenge.
A report unveiled by the IMS Institute for Healthcare Informatics highlights aspects of medication use and spending (Table1). According to the report, total spending on medications in the U.S. reached $310 billion in 2015, an 8.5% jump from the previous year. Major factors fueling growth included new branded products, generic spending, and expired patents.
New brands available for less than 2 years, notably specialty medicines, accounted for over half of the total spending growth. New brand spending increased by $24 billion, primarily driven by new hepatitis C treatments, such as ledipasvir/sofosbuvir (Harvoni, Gilead). Other specialty drugs steering growth include an easier dosing option for multiple sclerosis, a combination therapy for HIV, and treatments for autoimmune conditions and cancer. Traditional medicines, including SGLT2 inhibitors targeting diabetes and a new human papilloma virus vaccine, contributed 33% to new brand spending growth (see Drugs that are driving growth).
Table 2 shows the top 20 prescribed medications in the U.S. according to IMS health.
The IMS report also cites that generic spending increased by 7.4% -$7.9 billion-fueled by the availability of aripiprazole (Abilify, Otsuka), esomeprazole (Nexium, AstraZeneca), and celecoxib (Celebrex, Pfizer) generics. Branded generics, non-original medicines marketed with trade names, grew sharply on an invoice price basis.
IMS Health has not released a 2016 prescription drug spending report yet. In 2015, spending on oncology drugs increased 18% –to $39 billion: targeted therapies, such as monoclonal antibodies and protein kinase inhibitors, took the lead. These agents have shown efficacy against various tumor types by targeting gene mutations in cancer cells, while minimizing impact to surrounding healthy cells. Monoclonal antibodies accounted for 35% of total spending, driven both by novel PD-1inhibitors and existing treatments. PD-1 inhibitors target immune checkpoints and act as an “off switch” that helps to keep T-cells from attacking other cells. The agents have demonstrated efficacy against many tumor types, including melanoma and hepatocellular carcinoma. Current game-changers, pembrolizumab (Keytruda, Merck) and nivolumab (Opdivo, Bristol-Myers Squibb), are undergoing more than 135 clinical trials for additional indications. The 27% increased spending on protein kinase inhibitors was mainly due to the recent approvals of palbociclib (Ibrance, Pfizer) and ibrutinib (Imbruvica, Janssen Biotech).
According to the IMS report, spending on diabetes medications also increased by 8.2% on a net basis in 2015, compared with 30.1% growth on an invoice basis. Insulins accounted for nearly half of the $10 billion invoice price growth; however, all of the increase was offset by rebates and price concessions. Additionally, invoice spending on DPP-IV inhibitors, SGLT2s, and GLP-1 agonists rose steadily.
Several new active substances (NAS) and non-NAS were also unleashed. NAS refers to a new molecular entity, new biologic agent, or a new combination drug in which at least one element is new. Oncology, infection, and neurological disorders were the most prevalent therapeutic areas, and account for majority of NAS launches in recent years. About a third of the NAS launched in 2015 had a FDA orphan designation, while the number of non-orphan drugs approvals was at its highest since tracking began in 2002. Approximately two-thirds of all orphan drugs were for oncology indications, while the rest targeted rare diseases, such as cystic fibrosis and hemophilia B.
Prominent non-NAS launches include rare disease treatments, and options offering improvements that address patient adherence and unmet needs. Five additional therapies for diabetic patients are now available, including the first inhaled insulin and options providing easier insulin administration. New HIV treatments were also unveiled, providing options against drug resistance and reduced pill burden.
The IMS report revealed that developments in biosimilars remain at high levels, with its first U.S. approval in 2015 and a growing pipeline on the horizon. Sandoz launched Zarxio (filgrastim-sndz), the first biosimilar approved via the biosimilar pathway, in August 2015. The first non-original biologics, Granix and Omnitrope, were previously approved through alternative FDA pathways. According to Ralph Boccia,MD, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION), “while biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general. Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies.” Seven biosimilar applications were pending via the FDA biosimilar pathway at the end of 2015, and others with The Prescription Drug User Fee Act (PDUFA) dates in 2016.
Pipeline Drugs and Future predictions
In November 2016, Mylan and Biocon announced the submission of a Biologics License Application (BLA) to the FDA for MYL-1410, the proposed biosimilar to traztuzumab (Herceptin, Genentech).
The investigational quinolone antibiotic, delafloxacin (Baxdela, Melinta Therapeutics), is being evaluated for the treatment of skin infections and community-acquired bacterial pneumonia. The drug has broad-spectrum activity, most notably against MRSA. Key advantages of the drug include no dose adjustment or monitoring requirements in obese patients, according to a phase 3 study presented at IDWeek 2015 in San Diego, CA.
Genentech’s anti PD-L1 cancer immunotherapy, Tecentriq (atezolizumab), received FDA approval for bladder cancer recently, and is set to be one of the best selling drugs in 2022, according to a report released by EvaluatePharma. Roche’s multiple sclerosis therapy, Ocrevus, and hemophilia drug, emicizumab, are projected to be potential blockbusters and have helped the pharma company claim the crown for the highest valued pipeline.
Monica Shah, PharmD is a Clinical Pharmacist at RWJ Barnabas Health in New Jersey and adjunct faculty member at Ernest Mario School of Pharmacy at Rutgers University.
Ledipasvir/Sofosbuvir (Harvoni®), a direct acting antiviral therapy that is specifically targeted as a NS5A inhibitor /NS5B polymerase inhibitor, was FDA approved in 2014 as the first once-daily tablet for hepatitis C virus (HCV) genotype 1 infection. In 2015, the FDA approved it for expanded indications for HCV genotypes 4, 5, and 6, in addition to recommending dosing in those who are co-infected with HIV and HCV. Moreover, those with genotype 1 who are treatment-experienced with cirrhosis may be eligible to receive Harvoni® with ribavirin for 12 weeks.1
Sofosbuvir/velpatasvir (Epclusa®) is another combination NS5B polymerase inhibitor/ NS5A inhibitor and is the latest drug approved, earlier this year, for HCV. It is the first regimen that can be used in genotypes 1, 2, 3, 4, 5, and 6 alone in those without cirrhosis or in those with Child-Pugh A. In those with decompensated cirrhosis (Child-Pugh B or C), it would be combined with ribavirin. It was approved on the basis of four randomized trials, ASTRAL-1, 3, and 4 with high sustained virilogical response and tolerable adverse effects.2
Glatiramer acetate (Copaxone®) is a disease –modifying injectable drug approved in 1996 for relapsing forms of multiple sclerosis (MS).3 In 2015, a generic form of the drug, GlatopaTM , was approved in an effort to reduce prices and increase access to patients who cannot afford the drug. The main difference in dosing is that Copaxone comes in 20mg/mL to be given subcutaneously daily or the 40mg/mL to be given three times a week . GlatopaTM was approved in the 20mg/mL dosing only. The dosing is not interchangeable for the 40mg/mL strength.4
Dimethyl Fumarate (Tecfidera®) is a twice daily oral disease-modifying drug approved in 2013 for relapsing forms of MS. Although its mechanism is not fully known in MS, it is thought to be involved in enabling cellular response to oxidative stress caused in MS. Dimethyl fumarate’s product information was updated recently to highlight progressive multifocal leukoencephalopathy (PML) as an adverse effect.5
1. Harvoni [product information]. Foster City, CA: Gilead Sciences, Inc.; Updated 2016
2. Epclusa [product information]. Foster City, CA: Gilead Sciences, Inc.; 2016
3. Copoxone [product information]. North Wales, PA: Teva Pharmaceuticals, Inc.: Revised 2016
4. Glatopa [product information]. Princeton, NJ: Sandoz Inc. (a Novartis company): 2015