ReportersNotebook — Chain Pharmacy, 2/27/12
SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.
The FDA has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said. The FDA approved Novartis’ Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors. The drug was originally approved in 2001 for a type of leukemia.
Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said. Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for hypertension.
The FDA has approved a head lice treatment made by Sanofi, the drug maker said. Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice affects an estimated 6 million to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.
The FDA has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said. Mylan announced that it had received tentative approval for a generic version of Pfizer’s Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths. A tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer’s version and will until May. Lipitor had sales of $8.2 billion in 2011, according to IMS Health.
COPD pipeline grows despite patent cliff
One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.
One market that still seems to be doing fairly well is chronic obstructive pulmonary disorder, which comprises emphysema and chronic bronchitis. The disease affects more than 13 million Americans, and an additional 12 million may have it without knowing it, according to the National Institutes of Health. In addition, it’s the third-leading cause of death, claiming the lives of more than 120,000 Americans each year.
In response, drug development has continued at a brisk pace. According to the Pharmaceutical Research and Manufacturers of America, more than 50 drugs are currently in clinical development for treating COPD, ranging from pharmaceutical drugs to stem-cell therapies that attack the biological mechanisms behind the disease.
Some new drugs for the condition already have hit the market. In October 2011, the FDA approved Boehringer Ingelheim’s Combivent Respimat (ipratropium bromide and albuterol sulfate), which is delivered in a propellant-free inhaler that uses a slow-moving mist to deliver the same active ingredients as the Combivent Inhalation Aerosol. The company expects to launch the drug in the middle of this year.
In November, generic drug maker Mylan bought rights to a drug delivery platform made by Pfizer that would allow it to manufacture and commercialize generic versions of GlaxoSmithKline’s Advair Diskus and Seretide Diskus (fluticasone propionate and salmeterol).
Where everyone wants to be … but how to get there?
“I have 20 years in the retail sector, and I know that not every pharmacist can be a specialist in a retail environment. So we give the pharmacists a higher level of confidence by using technology to target specific [national drug codes]. If a limited- distribution product or a specialty script that they either don’t stock or they have never seen before comes across the counter, the computer directs them to Hy-Vee Pharmacy Solutions. Now they can tell the patient, ‘Yes,’ instead of ‘I’m not sure if I can help you,’ or ‘We don’t stock that medication.’”
That’s how Mike Agostino, president of Amber Pharmacy, described his company’s relationship with Hy-Vee, a chain of 230-plus supermarket pharmacies spread throughout the Midwest, during our annual DSN Industry Issues Summit/Specialty Pharmacy Roundtable in late November. The complete transcript is available online at DrugStoreNews.com/SpecialtyPharmacy — it’s a must-read for any one who needs to understand the critical issues facing specialty pharmacy today and in the years to come.
And according to OncoMed CEO Burt Zweigenhaft, another member of our panel, that includes just about everyone who makes their business in pharmacy: “Specialty pharmacy is 50% of the market; it’s 50% of the growth. It’s where everyone in pharmacy wants to be,” he implored his fellow panelists.
I‘ve been giving a lot of thought to these comments over the last several weeks, which have included a busy travel schedule. In 4-of-5 trips, the subject of specialty pharmacy was a major topic of conversation. Zweigenhaft is right: Specialty pharmacy is where everyone in pharmacy wants to be. The million-dollar question is how to get there?
According to IMS VP industry relations Doug Long, who spoke Feb. 6 at the National Association of Chain Drug Stores Regional Chain Meeting on current trends and forecasts for the U.S. pharmaceutical market, specialty pharmacy dollars are growing more than 10% on a 12-month moving annual total basis.
Where is that business landing? Mail order is the big winner, with about $20 billion worth of the market, and clearly pacing the growth in specialty pharmacy, with dollar sales up more than 16%, during the same 12-month period. In chain pharmacies, specialty pharmacy is worth about $8 billion, Long said, up about 1.6%. And while the base is much smaller at about $4.2 billion, independent drug stores were growing specialty pharmacy dollars at more than 5%.
There were 35 new drug approvals in 2011 — the second largest yearly amount in more than a decade, Long said, and most of these were specialty drugs. The current new drug development pipeline is expected to bring more of the same for many years to come. It will be critical for pharmacy retailers like the regional chain executives Long addressed in February, “to capitalize on as many of these opportunities [in specialty pharmacy] as possible,” he said.
That doesn’t mean that every pharmacy chain in America needs to make an internal commitment to specialty pharmacy. It doesn’t work in every store, and certainly not every pharmacist can be a specialist in some of these more advanced disease states. But business relationships like the partnership Amber has with Hy-Vee and the hundreds of providers that make up networks like the Armada Specialty Pharmacy Network, can facilitate the delivery of specialty pharmacy in a manner that is transparent to the patient; all they know is their preferred pharmacy continued to provide all of their pharmacy needs.
Long’s comments reminded me of something that I had believed for a long time — as the specialty pharmacy market continues to grow, the universe will continue to expand as well. Not every pharmacy will play the same role. Big pharmacy retailers like CVS and Walgreens will do it themselves. Retailers like Hy-Vee will find partners.
I agree with Burt Zweigenhaft: Specialty is where everyone in pharmacy wants to be right now. And this is how they are going to get there.
Rob Eder is the editor in chief of The Drug Store News Group, publishers of Drug Store News, DSN Collaborative Care and Specialty Pharmacy magazines. You can contact him at [email protected].