Orphan drugs to see growth through 2018, report finds
NEW YORK — Drug makers could strike big with new treatments for rare diseases, according to a new report by a market research firm.
According to analysis by GBI Research, the orphan disease therapeutics market will see an increase in value through the decade, increasing from 2010’s $2.3 billion to $6 billion in 2018. Currently, there are more than 6,000 orphan diseases recognized in the United States, defined as diseases affecting 200,000 or fewer Americans and including such conditions as Gaucher disease and Fabry disease. European health authorities recognize between 5,000 and 8,000 of them. The report focused on the United States, Japan, the United Kingdom, Germany, France, Italy and Spain.
The report found that the need for an improved and expanded selection of drugs would boost research and development, some of which already has been taking place: On Wednesday, the Food and Drug Administration approved Elelyso (taliglucerase alfa), a treatment made by Pfizer and Protalix BioTherapeutics for Type 1 Gaucher disease. Genzyme, now a subsidiary of French drug maker Sanofi, historically has been a leader in developing drugs for orphan diseases, but some of its drugs have experienced shortages due to manufacturing problems in recent years.
Walgreens Specialty fortifies oncology service with six new oral therapies
DEERFIELD, Ill. — Walgreens Specialty Pharmacy on Thursday added six medications to its oral oncology cycle management program, in a significant expansion of the comprehensive treatment and support program it provides to benefit patients, physicians and payers, the company announced.
“Taking oral oncology medications as prescribed can be difficult for many patients, and this program has proven to be successful in improving patient outcomes while also lowering costs for patients and payers,” stated Michael Nameth, EVP Walgreens Specialty Pharmacy. “Expanding our cycle management program allows us to provide enhanced care and support to more patients as they cope with challenging oral oncology regimens.”
The additional medications now available to patients being treated for cancer through Walgreens Specialty Pharmacy’s cycle management program are: Afinitor and Votrient for kidney cancer; Sprycel and Tasigna for leukemia; and Targretin and Zolinza for lymphoma. The program previously included three primary cancer drugs: Nexavar for kidney and liver cancers, Sutent for gastrointestinal stromal tumor and kidney cancer, and Tarceva for non-small cell lung and pancreatic cancers.
The program, which launched in 2008, features regular monitoring of patients, as well as a “split-fill” dispensing system in which only half of the first month’s supply of medication is filled initially. This allows Walgreens clinicians to follow up with patients to monitor response to treatment and potential reactions or side-effects, helping to avoid medication waste and costs associated with early therapy discontinuation. And based on the cost of these oral agents, the waste avoidance can save payers between $2,000 and $4,000 per month, per patient.
Oral oncology medications often cost individual patients and their insurance providers thousands of dollars per month, Walgreens reported. The cycle management program saved more than $3 million combined during the first three months of therapy among 1,740 patients, through significant reductions in medication waste and improved adherence to medications, according to a Walgreens analysis.
J&J seeks additional approval for anti-clotting drug
RARITAN, N.J. — Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.
J&J division Janssen Research & Development announced the submission of a supplemental new drug application for Xarelto (rivaroxaban) to the FDA for the two conditions and for preventing recurrent venous thromboembolism.
The submission was based on three trials of the "EINSTEIN" program, which enrolled more than 9,400 patients around the globe. Xarelto, an anticoagulant, already is approved for reducing the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery, and to reduce the risk of stroke and other complications related to migrating blood clots in some patients with atrial fibrillation. J&J is developing the drug with Bayer HealthCare.