Showing posts with label pharmacy benefits management. Show all posts
Showing posts with label pharmacy benefits management. Show all posts

Wednesday, May 24, 2017

Specialty Drugs: Confronting the Rising Price of Progress

By Scott Holtmyer, R.Ph.



Specialty drugs are expensive. A broad set of medicines for chronic or life-threatening diseases, they are often capable of providing an unprecedented quality of life. But while company health plan members may pay only a fraction of the price out of their own pockets, employers know that offering these drugs is an ever-costlier obligation.
At Script Care, we administer pharmacy benefits for millions of lives, and we see the dramatic impact of specialty drug costs on employer plans every day. For example, a small group adding just one person with a rare autoimmune disorder could see its total pharmacy costs double. Situations like these are precisely why our clients look to us for help.
As recently as 2000, it was rare for specialty drugs to exceed 10% of a plan’s total cost. By 2010, 10% was the norm. In 2014, an article in the journal Health Affairs reported 15% annual growth in US specialty drug spending, which was “expected to account for approximately half ($235 billion) of total annual pharmacy spending by 2018.”1 By 2015 we were already seeing specialty account for up to 40% of pharmacy costs for some Script Care plans.
In a sense, skyrocketing prices are a symptom of scientific success. Specialty drugs help people with rheumatoid arthritis go to work and live without pain. Patients with severe multiple sclerosis, who would otherwise require numerous hospitalizations, can now enjoy a better quality of life. In 2014, Scientific American reported on a hepatitis C treatment that cured over 90% of patients. The article’s headline was revealing: “We Now Have the Cure for Hepatitis C, but Can We Afford It?”2 Today, the treatment applies to four different variants of the virus, including the one that is most common in the US.
Other specialty drugs offer breakthroughs for conditions that never had a drug before, meaning there are more people who can be treated. 25 million people in the US have a rare “orphan” disease. Their drug treatments can cost $300,000 per year.
Meanwhile, doctors today can diagnose conditions like multiple sclerosis far earlier than once was possible. This is good news for patients and families, but it also adds years of high drug costs to an employer’s pharmacy plan.
There is no legal limit to what manufacturers can charge for these drugs, and high prices encourage the development of more specialty products. Of the 22 novel drugs the FDA approved in 2016, nine were for orphan diseases.3
As specialty drug costs continue to challenge employers, we at Script Care challenge ourselves to help control these costs. Our tactics include ensuring proper treatment, creating specialty drug formularies, implementing smarter co-pays, and limiting a member’s day supply per prescription fill.
Solution 1: Proper Treatment
At Script Care, our top priority is to have the right drug matching the right diagnosis for the right person at the right cost. Non-alignment can bring tremendous cost. Script Care once identified a third party laboratory error that could have cost a client $100,000 in unnecessary medication for one of their employees. It shows why we work so hard to avoid mistakes.
Solution 2: Specialty Drug Formularies
Formularies are lists of preferred drugs covered by our plans. Taking advantage of increased competition in the specialty drug market, we choose drugs for our formularies that give our members the best value.
For example, there are ten drugs available for rheumatoid arthritis, with three more in the pipeline. This allows us the flexibility to select effective treatment at a lower cost. There are formulary alternatives to every non-formulary specialty drug a member might be prescribed.
Solution 3: Smarter Co-Pays
To stay competitive and ease the burden on consumers, specialty drug makers often offer co-pay assistance. If tracked improperly, this can strain the obligation on employer plans.
For example, imagine a $1,000 copay on a plan with a $7,000 out-of-pocket maximum. A member might pay only $5 per month with co-pay assistance. If the plan does not account for the assistance, it will record member “payments” of $1,000 per month. The member will thus meet plan’s out of pocket maximum after 7 months, forcing the plan to cover 100% of the member’s remaining costs for the year. In reality, of course, the member has only paid $35.
Our copay assistance accumulator tracks a member’s actual out-of-pocket costs, ensuring that both members and employers contribute their fair share. Meanwhile, manufacturer co-pay assistance for the member continues as usual.
Solution 4: Limiting Day Supply
We limit our specialty medications to a 30-day supply. If we sent a 90-day supply of a specialty medication and the member had an adverse reaction after just a few weeks of treatment, we would waste the remaining medication.
Preparing For the Changes Ahead
2017 is a year of political change and policy uncertainty, especially for the healthcare sector. Alterations to the Affordable Care Act could change our current assumptions about drug prices, and we are closely monitoring legislative and regulatory developments.
In an industry with competing interests and complex incentives, our loyalty remains to our customers and the members they serve with their plans. Regardless of politics or price, Script Care will work tirelessly to keep costs reasonable and get people the treatment that they need.
Scott Holtmyer is the Director of Clinical Services at Script Care, a pharmacy benefits manager.
1 HEALTH AFFAIRS , SPECIALTY MEDICATIONS: TRADITIONAL AND NOVEL TOOLS CAN ADDRESS RISING SPENDING ON THESE COSTLY DRUGS (October 2014).
2 SCIENTIFIC AMERICAN, WE NOW HAVE THE CURE FOR HEPATITIS C, BUT CAN WE AFFORD IT? (September 2014).
3 U.S. FOOD AND DRUG ADMINISTRATION, 2016 NOVEL DRUGS SUMMARY (January 2017). 

Thursday, January 19, 2017

Stats of the year: 2016 By the Numbers

A review of the 2016 statistics from the multiple facets that make up the healthcare arena includes: 

  • Television Commercials: A combined 1.3 million ads for prescription and over the counter drugs, raking in an estimated revenue of $4.6 million.
  • Opioid Deaths: A nearly 20% increase in overdose deaths in Massachusetts attributed to the synthetic opioid, fentanyl.
  • Expensive Drug Treatments: Only 3% of Kentucky Medicaid participants were able to receive hepatitis C treatments – a sign of the epidemic burdening the Medicaid system nationwide.
  • Growth in Biotech: Private biotech companies received nearly $4 billion less in venture capital investment than in 2015.


 Additional topics include the gene editing technology, CRISPR; stem cell treatment facilities; the impact of Zika on birth rates in Columbia; and hospice care utilization.

Read STAT News' article on it here.

Monday, September 26, 2016

The Pluses, Minuses of Drugmakers' Discount Cards

While discount cards can assist patients in covering out-of-pocket expenses, their use by drug manufacturers to steer users to more expensive drugs ultimately drives up costs in the healthcare system. Many coupons and discount cards are targeted at expensive brand name medications; while they allow the patient to afford their established copay, the insurer is paying the balances of a significantly more expensive drug than the generic or preferred brand – oftentimes, leading to higher premiums the following years. Further, these discounts are usually limited to a certain number of fills or restricted timeline and cannot be used by patients in federal health plans.

Read Drug Discovery & Development's article on it here.

Friday, September 16, 2016

[Medscape Podcast] Biosimilars: Can They Be Trusted?

Podcast summary: The first biosimilars were released in Europe ten years ago and were based on biologics with fairly simple structures. As technology and understanding expands, manufacturers are approaching a more complex set of drugs; some critics worry that, while researchers are able to easily map the sequence of proteins, the actual structure of a biosimilar may have slight, undetected variations from its counterpart. Industry experts, however, are confident that the advancement of the technology used to compare the chemical makeups is so precise that any undetected structural error would be too minor to impact the drug’s efficacy or safety. Additional concerns stem around clinical trial requirements – while the original biologic required rigorous testing with thousands of people, trials to prove equivalence (rather than efficacy) are typically much smaller in nature. On the other hand, equivalence studies are much more affordable, lending this approach to the cost containment initiatives that make biosimilars attractive in the first place. Further, regulatory agencies will also likely require extensive additional evidence of drug similarities, supplementing required trials, before any approvals are issued.

Hear Medscape's podcast here.

Tuesday, August 30, 2016

Podcast: Aetna Letter Sparks Controversy

Summary: After announcing an exit from the majority of the healthcare exchanges in which it currently operates, Aetna is receiving criticism over a letter it had previously sent to the Department of Justice (DOJ). In it, Aetna’s CEO stated that if the merger between his organization and Humana was blocked, the company would have to leave the exchange business. Aetna claims to have left due to financial concerns and profitability issues with the program setup, but some wonder if the letter was meant as a veiled threat. Experts point out that if the latter is true, the attempt was misguided – the DOJ typically does not consider political pressures when examining anti-trust cases and is attempting to block the merger regardless of the letter’s intent.

Hear the full podcast from Marketplace here.

Monday, August 1, 2016

Fearing Zika, FDA Asks Two Florida Counties to Halt Blood Donations

After travel and sexual transmissions were ruled out for four Zika cases in Florida counties of Miami-Dade and Broward, fears of infected mosquitos in the United States are mounting. Because the virus does not present symptoms in many cases, it is possible that more people are infected – and may have donated blood after being bitten. The FDA has issued a warning that blood collections in the counties should not resume until they are able to properly test the blood and screen donors; they also recommend that neighboring and other at-risk counties consider taking the same actions.

Read NPR's article on it here.

Thursday, July 21, 2016

Sanders, Other Lawmakers Urge FDA Approval of Generic Crestor

Two months ago, AstraZeneca gained approval for the use of Crestor in children suffering from homozygous familial hypercholesterolemia (HoFH) and, under the Orphan Drug Act (ODA), the drug then qualified for extended market exclusivity for the treatment of this new condition. With the impending loss of patent protection for Crestor’s common use in adults, AstraZeneca has filed a lawsuit accusing the FDA of illegally interpreting a federal law that will allow generic medications to exclude indications for HoFH on their labels. Without the ruling, generic manufacturers would be required to include HoFH dosing and instructions on their labels, therefore violating the exclusivity granted by the ODA and extending AstraZeneca’s market hold. Bernie Sanders, along with several other lawmakers, are petitioning the FDA to approve the generics and offer a lower cost alternative to consumers.

Read the Stat News article on it here.

Wednesday, June 22, 2016

'Cross Protection' Occurs Between Bacterial Strains

Scientists recently discovered a mutually beneficial relationship occurring between bacterial strains: cross protection. In a new study, researchers grew two types of E. coli, each resistant to a different antibiotic, in the same test tube. The environment also contained the two antibiotics to which the strains were resistant. Instead of being eliminated, both bacteria deactivated “their” antibiotic, providing protection for the other strain. While not occurring in this study, experts suspect that, over time, this stable environment could lead to the exchange of resistance genes – making both strains of bacteria resistant to both antibiotics.

Listen to Scientific American's podcast about it here.

Wednesday, May 25, 2016

GlaxoSmithKline CEO On Why Drugs Cost So Much

Sir Andrew Witty, the CEO of Britain’s GlaxoSmithKline (GSK), the sixth largest pharmaceutical company in the world, discusses the current period of ‘extreme challenge’ in the industry and acknowledges the disconnect between the global push for affordable healthcare and the current cost of needed medications. Specifically, he points to the U.S.’s lack of transparency requirements as a major driver for the issues that our country is facing today – an inability to determine the actual price of a drug makes it impossible to determine a realistic cost-benefit analysis for the system. Ultimately, he suggests, the system needs to balance cost, value and innovation to ensure shareholders remain invested and patients have access to the drugs they need.

Hear the podcast on it here.

Thursday, April 28, 2016

New 'Scarier' Zika Warnings in the U.S.

The CDC recently released a broader range of Zika-related complications beyond microcephaly, including stillbirth, placenta damage, prematurity, etc., as well as potential links to additional non-pregnancy conditions. In this comprehensive discussion about the existing and anticipated impact of the virus, experts explain the developing understanding of transmission, effects and prevention. Although there is evidence that the disease is not in the continental US (beyond those that traveled to infected countries), experts estimate the range of the carrier mosquito to include parts of at least 30 states – with an additional potential carrier type extending as far north as Minnesota. Combined with the difficult of containment, due to the uniqueness of the mosquito (including breeding, biting habits, etc.), experts suspect that an outbreak in the United States would be the “public health version of [Hurricane] Katrina.”

Listen to the podcast about it from On Point with Tom Ashbrook.

Monday, December 28, 2015

Gilead Put Profit Ahead of Hepatitis C Patients: U.S. Senate Report Says

The Senate Finance Committee has determined that the prices charged by Gilead for the Hepatitis C drugs, Sovaldi and Harvoni, do not reflect the actual research or cost incurred in producing the drugs and is officially accusing Gilead of placing profits ahead of affordability and accessibility. In 2014, Medicare and Medicaid spent more than $5 billion on Sovaldi and Harvoni. Gilead released a statement saying that with available rebates and discounts the cost is actually less expensive than that of prior treatments, and, additionally, the improved efficacy of their drugs reduce the cost of future medical complications.

To read the full Reuters article click here.

Friday, December 11, 2015

Pfizer to Buy Allergan in $160 Billion Deal

Pfizer’s announcement that it will buy Allergen (the producer of Botox) will shift the manufacturer’s headquarters to Ireland and help reduce their incurred domestic taxes by an estimated 8%. The deal will make Pfizer the largest company in the industry, as well as mark the largest instance of an international acquisition to lower a U.S.-based company’s taxes – and has earned direct criticism from President Obama, Hillary Clinton, Bernie Sanders, and Donald Trump. Both companies saw a drop in their stock prices after the announcement.

Read Reuter's article on it here.

Monday, November 9, 2015

Statins May Dampen Protective Powers of Flu Vaccines

Two new studies highlight a potential relationship between statin use and flu vaccine effectiveness in seniors; however, experts warn that studies are preliminary and the benefits of both medications outweigh any negative interactions. The findings, however, add to the list of questionable side effects of the popular cholesterol-lowering drugs, associating statin use with muscle pain, liver damage and memory loss. One study found that vaccine-recipients taking statins had 38-67% fewer flu antibodies than those not taking statins (with natural statins appearing to be less detrimental than synthetic.)  The second study more specifically identified an inflammatory interaction between statins (thought to improve cardiac health by reducing inflammation) and the vaccine (priming the body to avoid the flu through increased inflammation.) Alternatively, the reduced inflammation of statins may help fight the flu once it is infected.  These findings indicate that additional research will be needed before conclusive results can be published.

Read the article here: consumer.healthday.com

Thursday, October 15, 2015

Protein Sciences Reports Flublok Vaccine Now Available Nationwide

Flublok will now be available for walk-in vaccinations at Target, Mariano’s, Roundy’s, and Brookshire’s nationwide; with the suggestion that patients call ahead to confirm availability at other pharmacies. Flublok is the only vaccine on the market that is free of formaldehyde, antibiotics, gluten, gelatin, egg protein, latex, thimerosal and other preservatives. Further, Flublok resulted in nearly 50% fewer influenza cases in older adults than an alternative egg-based influenza vaccine.

For more information, read the full news release here: www.drugstorenews.com.

Wednesday, September 30, 2015

DrugGoes From $13.50 a Tablet to $750, Overnight (www.nytimes.com)

Daraprim, a 62-year-old drug used to treat the life-threatening parasitic infection, toxoplasmosis, experienced a dramatic price hike after being acquired by the start up Turing Pharmaceuticals, run by former hedge fund manager Martin Shkreli. While Shkreli maintains that the cost hike will fund new research in treating toxoplasmosis and is now in line with the costs associated with treatment for other rare disease, physicians and members are not pushing for drug reformulation as the associated side effects of Daraprim can be easily managed. The price increase is in line with Shkreli’s developing reputation for questionable profit acquisition in the drug arena: in 2011, he started another company whose primary focus was acquiring old drugs and increasing their prices; prior to that, he worked to stall drug approvals made by companies whose stock he was short selling.

Shkreli is not alone in the business of, seemingly, questionable drug price hikes: this year alone, Cycloserine, a tuberculosis drug, and Isuprel and Nitropress, both heart drugs, experienced dramatic price increases after they were acquired by other drug companies. Even Daraprim’s price increased from $1 a tablet to $13.50 after it as acquired by CorePharma, prior to Turing’s acquisition this year.

Monday, September 14, 2015

Reuters.com: Kmart Pays $1.4 Million to Settle U.S. Charges Over Medicare Inducements

Kmart is accused of allowing Medicare beneficiaries to use manufacturer coupons to reduce pay and provide access to expensive brand medications instead of the preferred generic options, as well as offering gasoline discounts based on prescription volume. The practices violate the False Claims Act, which prohibits offering Medicare users benefits to influence pharmacy utilization, forcing the company to pay $1.4 million to the government to settle the suit.

Tuesday, August 4, 2015

Merck & Co. is entering the Hepatitis C market by targeting hard-to-treat and advanced stage patients; this approach opens up a new market space for the drug manufacturer instead of competing with Gilead Science’s Harvoni and/or Sovaldi or AbbVie Inc.’s Viekira Pak for patients in earlier stages of the disease. The advantage of Merck’s treatment beyond those currently available is its tolerance by patients with ‘substantial renal insufficiency,’ an important feature, as a large portion of patients on dialysis are Hep-C infected and no other treatment for this population exists today. Gilead is currently testing its drugs on patients with severe renal insufficiency, but is only approved for patients with mild or moderate kidney impairment (as is Viekira Pak). Merck is also investigating the additional avenue for identity by gaining approval for various subtypes of the virus: Genotypes 1, 4 and 6.  All three makers are currently working to develop a single treatment for all six subtypes of the disease.

You can learn more by reading the www.bloomberg.com article, MerckTargets Toughest Cases to Gain Hepatitis C Foothold