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Friday, July 12, 2019


Trump Administration Drops Rebate Plan


On July 11, 2019, the Trump administration announced that it will not be moving forward on a proposed rule to eliminate arcane rebates that flow from drug manufacturers to the PBMs (Pharmacy Benefit Managers). Many employers were concerned that this ruling would have a trickle down effect and conceivably mandate that they also would be required to provide rebates for certain drugs to certain members at Point of Sale. That concern is now alleviated.

The draft measure, which was projected to raise federal spending by $177 billion over the next decade, was poised to prohibit drug rebates for treatments offered in the Medicare and Medicaid programs beginning in 2020. This drew intense backlash from the PBMs, whose operations would be significantly impacted by this action. It also drew praise from drug companies that routinely blame PBMs as the cause of the high cost of drugs.

Top PBMs, like CVS Health, warned that removing the rebates would lead to higher drug costs for seniors, an outcome that sources say the White House was concerned about before the 2020 elections.

In another blow to the pharmaceutical industry, Trump is weighing an executive order to tie prices for Medicare Part B drugs to the lowest cost available internationally, an action that would undermine profits in the sector.

Monday, April 22, 2019


PBIRx has a New Look!

We’re still the same company, but we have updated our materials to better communicate who we are and how our products and services support your quest for better and more affordable pharmacy benefit plans!   

Data and creative cost savings solutions require “very specialized thinking” and we are proud and fortunate of the team we employ with their varied expertise, intelligence, and longevity in the industry and with PBIRx.








Bold letter forms represent our confidence and tenacity in everything we do.

The Brain represents our capacity to combine our comprehensive and analytical understanding of pharmacy benefits.  Our recommendations are based on right-brain/left-brain thinking.


The Tablets represent our focus on medications, formularies and clinical recommendation that provide better member benefit and health outcomes.

The Gradient Colors represent the dynamic, fast changing healthcare landscape.

PBI stands for Pharmacy Benefit Intelligence, which is what we live and what we deliver.

Our focus continues to be on our clients.  We evaluate current drug usage and spend, claim by claim, and then model and present alternative opportunities customized for each client which can yield measurable plan and member savings enhancing benefits while delivering optimum health outcomes.


PBIRx® has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal healthcare outcomes while minimizing overall healthcare costs. For more information, please visit www.pbirx.com or call (888) 797-2479.



Wednesday, April 17, 2019

Two New Drugs for Multiple Sclerosis


Two New Drugs for Multiple Sclerosis

The FDA has recently approved two new oral drugs for the treatment of Multiple Sclerosis (MS).
Over the last few years, three oral drugs for MS have become available: Gilenya came to the US market in 2010; Aubagio was released in 2012; and Tecfidera in 2013. Prior to that, all therapies were injectables.

Mavenclad (cladribine), an oral form of an older drug, given intravenously for certain types of leukemia, was FDA approved for the treatment of relapsing forms of MS  including active secondary progressive disease in adults. As a result of its safety profile, it’s generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Treatment with Mavenclad may increase the risk of malignancy.

Uniquely, Mavenclad is only administered twice over four or five days, for two treatment courses which are spaced about a year apart. After that, the patient doesn’t receive any medication for at least two years. The dose is weight-based; the total annual cost for an average 80kg person (176 lbs) is $127,900. Though it’s given much less frequently than any of the other currently available monthly oral medications, it is more expensive per month ($10,661).

Mayzent (siponimod), was approved for the same indication. The dose is also unusual: 0.25 mg once daily on Days 1 and 2; 0.5 mg once daily on Day 3; 0.75 mg once daily on Day 4; 1.25 mg once daily on Day 5. The maintenance dose is 2 mg once daily beginning on Day 6. The monthly cost is $8,729.

Only time will tell how these two new drugs will perform in the Multiple Sclerosis landscape.




PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal healthcare outcomes while minimizing overall healthcare costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Wednesday, March 27, 2019

Purdue Pharma to Pay $270 Million in Historic Lawsuit

Purdue Pharma has reached a settlement with the State of Oklahoma over claims the maker of the painkiller OxyContin helped fuel an opioid epidemic that killed thousands of residents in the state.  

Of the $270 million, nearly $200 million will go toward establishing the National Center for Addiction Studies and Treatment at Oklahoma State University in Tulsa, while local governments will receive $12.5 million.  Twenty million dollars will be set aside for addiction treatment medication, and the remaining $60 million will pay for the state's litigation costs to date.

Purdue, the make of OxyContin since 1996, faces more than 1,000 lawsuits in connection with the opioid crisis.  The Oklahoma deal is the first settlement to emerge from the thicket of lawsuits.

Drugs like OxyContin, along with illegal opioids such as heroin, were linked to a record 48,000 deaths across the United States in 2017 according to the CDC.  In Oklahoma, some 400 deaths were related to opioids that year.  According to state figures, more Oklahomans have died from opioids over the last decade than vehicle accidents.

Purdue Pharma is reportedly considering bankruptcy.



PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal healthcare outcomes while minimizing overall healthcare costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Thursday, December 6, 2018

Vitrakvi Drug - $32,000 per Month



On November 26, 2018, the FDA granted accelerated approval for Vitrakvi (larotrectinib), the first-ever neurotrophic receptor tyrosine kinase inhibitor. Vitrakvi is also the first treatment to receive a “tumor-agnostic” (not specific to an area of the body) indication at the time of initial FDA approval. 

Research has shown that the NTRK genes can become fused to other genes abnormally, resulting in growth signals that support the growth of tumors. NTRK fusions are rare but occur in cancers arising in many sites of the body. 

"(This) approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body," said FDA Commissioner Scott Gottlieb, M.D. "This new site-agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine.”

The full indication for Vitrakvi is intricate. It is to be used for the treatment of adult and pediatric patients with solid tumors that:
  •          have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
  •          are without a known acquired resistance mutation
  •         are metastatic

Or
  •          where surgical resection is likely to result in severe morbidity
  •          have no satisfactory alternative treatments

Or
  •         have progressed following treatment.

Vitrakvi demonstrated a 75% overall response rate across different types of solid tumors. These responses were durable, with 73% of responses lasting at least six months, and 39% lasting a year or more at the time results were analyzed. Examples of tumor types with an NTRK fusion that responded to Vitrakvi include soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer and lung cancer.
Vitrakvi comes with a hefty price tag: $32,000 per month. Bayer will help patients with copays and will provide free drug if the patient cannot afford it. Along the lines of value-based care, Bayer will also refund money spent by insurers or government payers if there is no clinical improvement in the first 3 months of treatment.
One reason the drug is so expensive is because this condition is very rare.  Bayer estimates only 2,500 to 3,000 patients in the U.S. develop cancer due to a TRK fusion each year. 
For more information: 


https://www.forbes.com/sites/matthewherper/2018/11/26/loxo-and-bayers-amazing-drug-has-an-expensive-price/#770ebfb624d0 

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal healthcare outcomes while minimizing overall healthgcare costs. For more information, please visit www.pbirx.com or call (888) 797-2479.


Friday, September 7, 2018

Flu Season 2018-2019




Flu Season 2018-2019

Influenza viruses typically circulate in the United States annually, most commonly from late fall through early spring. Most who are diagnosed with the flu will recover without any real issues; however, influenza can cause serious illness, hospitalization, and death, particularly among older adults, very young children, pregnant women, and those with certain chronic medical conditions.

Routine annual influenza vaccination of all persons aged ≥6 months without contraindications continues to be recommended. No preferential recommendation is made for one influenza vaccine product over another.

There are different types of vaccines available:
      Trivalent (3 strain) variety:
      Standard 3 strain shot (for ages 18-64)
      High-dose 3 strain shot (for ages 65 and older)
      Recombinant egg-free 3 strain shot (for ages 18 and older and pregnant women)
      Quadvalent (4 strain) variety
      Intradermal (under the skin) version
      Standard 4 strain shot (for ages 4 and older)
      Recombinant 4 strain shot (for ages 18 and older and pregnant women

Due to the unpredictability of timing of the onset of the flu season, and concerns that vaccine-induced immunity might diminish over the course of a season, it is recommended that vaccination should be offered by the end of October. Children aged 6 months through 8 years who require 2 doses should receive their first dose as soon as possible after the vaccine becomes available, to allow the second dose (which must be administered ≥4 weeks later) to be received before the end of October. Re-vaccination later in the season of persons who have already been fully vaccinated is not recommended. 

Optimally, vaccination should be received before flu activity is seen in the community. The ideal time to start vaccinating cannot be predicted because the timing of the onset, peak, and decline of influenza activity varies; more than one outbreak might occur in a given community in a single year. In the United States, localized outbreaks that indicate the start of seasonal influenza activity can occur as early as October.  About 75 percent of the past seasons saw a peak of influenza occur in January or later, sometimes even as late as February.

It is important to take preventive actions to stop the spread of germs during the flu season.  The CDC recommends staying at home for at least 24 hours after fever is gone, cover your nose and mouth when coughing or sneezing, wash hands often with soap and water (alcohol based hand rub will do if water is not available) and clean and disinfect surfaces and objects that may become contaminated.


PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.



Friday, June 8, 2018

To Promote Lower Cost Drugs Including High Cost Specialty Meds, FDA Publishes Two New Draft Guidances


On June 1st, the FDA published two new "draft guidance" documents, which are recommendations for review and comments to address one of the many complex obstacles to timely generic and biologic drug launches.   Some of these obstacles are related to the current Risk Evaluation and Mitigation Strategies (REMS) program developed by the Brand manufacturer.   After 60 days, the "draft guidance" comments will be evaluated and new policies will be voted on and become effective with the goal to bring lower cost generics and biologics to the market sooner.

Currently the FDA requires certain Brand medications to have a REMS program provided prior to the approval of the drug.   The REMS document outlines serious safety concerns and employs tools beyond prescribing information to ensure that the benefits of a medication outweigh its risks. 

The FDA may also require certain "Elements To Assure Safe Use" (ETASU) such as requiring the provider to have specific training or experience, that patients using the drug be monitored, or that the drug is dispensed to patients with evidence of other documentation of safe-use conditions.  The ETASU may also include a system for the applicant to monitor, evaluate and improve a subscribed drug implementation.   Lastly, a REMS document must have a timetable for submission of assessments of the strategy. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf 

Once the period of Brand patent protection or exclusivity has lapsed, it seems that generic and biosimilar drug competition is not materializing judiciously.   Sometimes this is due to Brand drug manufacturers' tactics before and after the generic or biologic drug manufacturer seeks approval for market entry.  One example is restricting the sale of the Brand drug to the generic or biologic manufacturer, which typically requires an estimated 5,000 doses in order to run bioequivalence and bioavailability studies to prove that the generic is the same as the Brand.  

Mylan, one of the largest generic manufacturers, recently sued Celgene over their refusal to share samples of Revlimed, which costs approximately $180,000 per year.   In 2016, its third year on the market, Revlimed had $6.97B in sales, and given the initial $800M on research and development, Celgene continues to reap a significant ROI. The expiration date for the patent will be 2019, but Celgene’s delay strategies could allow the company to put off unrestricted competition from generics until 2026, which could cost an extra $45B to patients who need this cancer drug.     https://www.bloomberg.com/news/features/2017-12-20/the-loopholes-drug-companies-use-to-keep-prices-high    


After bioequivalency has been determined, Brand manufacturers make the negotiation time between the Brand and generic or biologic drug applicant a lengthy process often resulting in litigation.  This causes delays in the approval of the generic or biologic.   Brand manufacturers have used this litigation to their advantage delaying market entry.

The FDA's new "draft guidances" are an effort to address these issues currently delaying generic and biologic drug competition.   The two new FDA "draft guidances" are:   1) "Development of a Shared System REMS Guidance for Industry" and 2) "Waivers of the Single, Shared System REMS Requirement Guidance for Industry".  The objective is to shorten the time that a generic or biologic can launch.  In the first "draft guidance" Brand and generic/biologic applicants are encouraged to use an industry working group (IWG) or third party to expedite negotiations and develop a shared REMS Guidance and ETASU.    The second "draft guidance" allows the generic manufacturer an option to seek a waiver to obtain a separate and comparable REMS policy with ETASU in certain situations where the Brand manufacturer is not cooperating.   https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf 


These guidance reports are expected to translate to new policies and will be a major opportunity for client and member savings as they will allow lower cost generics and biosimilars to come to market earlier.  High cost biologics continue to represent not only 40%-50% of total pharmacy benefit dollars, but also a large percentage of medical costs i.e. infused drugs and drugs bought and billed by physicians.  However, physicians will have to agree that biologics are safe and that patients equally feel comfortable being prescribed a biologic versus the Brand reference or originator drug.

 At the same time Pharmacy Benefit Managers have a tremendous amount of control given that they develop formularies with preferred drugs from manufacturers who provide the highest rebate including some of the currently few biosimilars approved in the United States.  As biosimilars come to market sooner, losers will be the clients who are not using an independent pharmacy benefit consulting firm, thus leaving thousands of dollars as PBM profits for shareholders because they signed a three year PBM agreement, which has language excluding biosimilars from rebates.


PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.