Erin Johanek, PharmD, RPh

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, hepatitis B is the most common serious liver infection in the world, with over 292 million people living with a chronic infection. Though incidence is lower in the United States, up to 80,000 Americans will still become newly infected with hepatitis B each year and more than 2 million Americans are chronically infected. While many people infected with hepatitis B virus (HBV) may clear the virus in the acute phase (the first 6 months), some people are unable to clear the virus and it progresses to chronic hepatitis B.

“Treatment with one of the seven FDA approved antivirals, intended to reduce liver damage and extend patient survival, may require lifelong medication therapy,” says H. Kelley Riley, MD, chief medical officer, EnvisionRxOptions, a pharmacy benefits and services company headquartered in Twinsburg, Ohio. “Current antiviral therapy may be near $1,000 per month, therefore prevention strategies provide an effective way to significantly reduce spending.”

“Since hepatitis B can be both acute and chronic, it has a significant impact on both pharmacy and medical spend,” says David Calabrese, chief pharmacy officer at OptumRx and a member of the 

 editorial advisory board. “Commonly used oral antiviral therapies often must be taken indefinitely in order to maintain suppression of the hepatitis B virus; and long-term complications associated with hepatitis B, including liver disease and impairment, the need for liver transplantation, and hepatocellular carcinoma, drive up healthcare costs.”

Cost and cures are at the forefront of needs for new hepatitis B treatments.

“The ultimate goal is to identify drugs or a combination of drugs that will substantially increase the functional cure rate for the infection and potentially reduce the duration of time needed for therapy,” says Calabrese. “Several novel therapies in the pipeline for the treatment of hepatitis B show promise in early-stage data and the recent success of antiviral therapies for hepatitis C has also sparked interest and development for identifying cures for hepatitis B.”

• JNJ-3989 (formerly ARO-HBV, Arrowhead Pharmaceuticals/Janssen Pharmaceuticals) is a third-generation subcutaneously administered RNA interference therapy in phase 1/2 studies as a curative treatment for patients with chronic HBV.

• Inarigivir soproxil (Spring Bank Pharmaceuticals), is an oral treatment designed to selectively act within cells infected with HBV to inhibit viral replication and induce the cell’s antiviral defense. Inarigivir is also in phase 2 studies for treatment of HBV, conducted by Gilead Pharmaceuticals, as a combination therapy with Vemlidy (tenofovir alafenamide, Gilead) compared to Vemlidy monotherapy.

• Myrcludex B (bulevirtide, MYR Pharmaceuticals) is a first-in-class subcutaneously administered treatment currently in phase 2b studies for chronic HBV and hepatitis D virus (HDV) coinfection. According to MYR, HDV is the most severe form of viral hepatitis infection, it only occurs in people coinfected with HBV, and current treatment options are very limited.

How the Specialty Pharmaceutical Market is Changing

“In keeping with the trend of specialty medications, pharmaceutical manufacturers will likely set high prices for these drugs; and for payers, it becomes even more complex when multiple drugs from different brand manufacturers are used in combination to increase the likelihood of a functional cure of hepatitis B,” says Calabrese. “PBMs are essential partners with physicians, patients, and payers in managing complex diseases like hepatitis B and using specialty pharmacy management to improve health outcomes and reduce costs while ensuring affordable access to needed medications.”

“Payers should be cognizant of preventive guidance; there may be increased encouragement to screen for HBV and administer preventive vaccination to a broader scope of individuals,” says Riley. “Treatments for those with chronic hepatitis B are still long-term and costly; and future pipeline treatments may be curative, which as seen in hepatitis C, could come with a high cost for a short amount of time. The future will most likely be a continued push for screening and prevention. Due to the global need to treat chronic hepatitis B, manufacturers are likely to continue research and conduct development to pursue a cure for hepatitis B.”

How Payers Are Keeping Specialty Drug Costs Down

Erin Johanek, PharmD, RPh is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio

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Why cost and treatment length are some of the biggest concerns for drug manufacturers.

The Latest in the Hepatitis B Drug Pipeline

According to the American Academy of Family Physicians (AAFP), peptic ulcer disease (PUD) is a problem of the gastrointestinal tract characterized by mucosal damage secondary to pepsin and gastric acid secretion. The two most common types of peptic ulcers are gastric ulcers, located in the stomach, and duodenal ulcers, found in the proximal duodenum. Epigastric pain is the most common symptom of PUD, but other possible manifestations include dyspepsia, heartburn, and chest discomfort. Examples of symptoms that warrant prompt referral to a gastroenterologist include bleeding, anemia, unexplained weight loss, and recurrent vomiting.

According to AAFP, the annual direct and indirect healthcare costs of peptic ulcer disease are estimated at about $10 billion.

“The current treatment regimen of antibiotics and stomach acid reducers, like PPIs are fairly inexpensive and covered by most insurance plans. The prices vary but overall are very affordable,” says Megan Harrington, PharmD, clinical staff pharmacist at 

. “The higher costs stem from unrecognized symptoms that progress to hospitalizations or surgical intervention.”

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The most common causes of PUD in the U.S. are infection with 

) and the use of nonsteroidal anti-inflammatory drugs (NSAIDs). According to AAFP, 

 bacteria adhere to the gastric mucosa and result in increased gastrin levels, mucus production, and mucosal bicarbonate secretion, all of which favor ulcer formation. NSAIDs cause submucosal erosions and inhibit the formation of protective prostaglandins.

 will expand at CAGR of 2.8% during the forecast period 2016-2022, according “Global Market Study on Peptic Ulcer Drugs: North America to Lead in Global Market During Forecast Period 2016 – 2022, Driven by Increasing NSAID Consumption,” published by Persistence Market Research. Surge in consumption of NSAIDs due to growing prevalence of inflammatory diseases is the major factor driving growth of the global peptic ulcer drugs market. Other trends driving growth include:

increasing adoption of peptic ulcer drugs over surgery

prevalence of stress ulcers due to higher smoking rates

availability of affordable therapy due to improvement in service sector

increasing awareness toward disease management through government campaigns

Chronic side effects associated with long-term use of peptic ulcer drugs is the major factor hampering the growth of global peptic ulcer drugs market.

According to the Mayo Clinic, proton pump inhibitors (PPIs) and histamine receptor blockers (H2 antagonists) are two treatments commonly used for PUD. The PPIs, like Protonix (pantoprazole), Nexium (esomeprazole), and Prevacid (lansoprazole) and the H2 antagonists, such as Zantac (ranitidine) and Pepcid (famotidine), all work by reducing stomach acid production. Additionally, cytoprotective agents, like Carafate (sucralfate) and Cytotec (misoprostol), are used to protect the lining of the stomach and small intestine from acid to decrease the formation of ulcers.

“The current standard of care for patients at risk of PUD due to 

 or chronic pain management through NSAIDs is to co-prescribe PPIs,” says Shital Mars, CEO of Progressive Care Inc, a personalized healthcare services and technology company based in South Florida. “PPIs like Prilosec (omeprazole) should be taken 30 minutes prior to taking an NSAID to mitigate the risk of PUD in these patients. Physicians should also consider the patient’s gastrointestinal risk and long-term side effects prior to recommending any particular NSAID treatment.” 

 greatly reduces the recurrence of peptic ulcers. According to the 

 is typically treated with combinations of two or three antibiotics along with a PPI, taken concomitantly or sequentially, for periods ranging from three to 14 days. Bismuth subsalicylate may also be used in conjunction with these medications. For PUD secondary to NSAID use, the prompt discontinuation of NSAIDs is advised along with avoidance of smoking and alcohol and drug abuse. 

“With the addition of treatments for reducing stomach acid and recognition of the microbiology behind peptic ulcer disease, we have seen a declining trend in patient suffering from serious illness related to peptic ulcer disease,” Harrington says.

Currently, according to Harrington, the most promising pipeline candidates for treating acid-related conditions are in phase 3 trials in Japan and Korea. Those drugs, according to 

If those trials in Japan and Korea are successful, the companies will submit their results to the FDA for review. The drugs could then be approved for phase 4 research and monitoring.

Vonoprazan and tegoprazan belong to a new class of acid secretion inhibitors known as potassium-competitive acid blockers (P-CABs).

According to the manufacturer, vonoprazan inhibits proton pumps without the need for activation by acid and unlike PPIs, vonoprazan is not primarily metabolized by CYP2C19, which has gene polymorphisms that may affect efficacy. The drug is a once-daily immediate-release formulation and because it does not require an optimized formulation design, like enteric coating, the onset of action does not significantly differ among patients. Vonoprazan is already approved in Japan under the brand name Takecab and is available in 10-mg and 20-mg tablets.

Tegoprazan is also a P-CAB developed for the treatment of acid-related gastrointestinal diseases such as gastroesophageal reflux disease (GERD) and peptic ulcers. Tegoprazan is already approved in Korea under the brand name K-Cab Tab. According to Korea Biomedical Review, while PPIs need three to five days to become effective, P-CAB drugs suppress gastric acid secretion within one hour of being administered.

Journal of Clinical and Translational Gastroenterology

, P-CABs result in very fast, competitive and reversible inhibition of proton pumps and they offer a more rapid elevation of intragastric pH than PPIs while maintaining the same degree of antisecretory effect.

Erin Johanek, PharmD, RPh, is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.

The current and future treatments for the $10 billion condition.

Peptic Ulcer Disease Drug Pipeline: What You Need to Know

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New cancer drugs continue to offer patients hope. Here are eight of them.

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This year has been another year full of oncology approvals, proving that the oncology pipeline is robust with first-of-the kind molecules, competitor products for existing agents, and biosimilars, according to Jeremy Whalen, PharmD, BCOP, specialty clinical program director, oncology, Prime Therapeutics.

“As more is being discovered and understood within the tumor microenvironment and specific cancer genomics, it is being paired with the emerging precision oncology practice,” Whalen says. “Manufacturers are investing in these pathways and targets looking for the next paradigm shifting therapy.”

Prime is actively monitoring 15 products that could receive approval before the end of the 2018. “These would join the additional 13 new products that already received approval this year and the more than 20 products that had expanded approvals,” Whalen says.

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Jonathan R. Ptachcinski, PharmD, BCPS, BCOP, clinical pharmacist practitioner, University of North Carolina Medical Center, says the oncology pipeline is continuing to be robust with possible upcoming approvals in a variety of both solid hematologic malignancies. “Approvals are anticipated for multiple new agents as well as a number of biosimilar specialty medications which are likely to be approved at the end of 2018 and early 2019,” Ptachcinski says.

One novel mechanism is the one targeted by larotrectinib, (LOXO-101), a pan-TRK inhibitor under FDA priority review for adult and pediatric patients with locally advanced or metastatic solid tumors that harbor a NTRK gene fusion, he says. “Reports from phase 2 data suggest that the benefit is seen across multiple solid tumor types which may help justify acquisition costs,” Ptachcinski says.

The outlook for healthcare executives will continue to focus on balancing the cost of administration of new agents, according to Ptachcinski. “Specifically, I anticipate that they will want to ensure that these new agents possess an improvement in outcomes that is commensurate with the increased cost versus. a small-yet statistically significant-benefit. Also, executives may wish to evaluate whether reimbursement for the cost of new therapies at will least cover drug administration cost or potentially also allow for new bottom-line margin.”

Erin Bastick, PharmD, RPh, is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.

This year has been another year full of oncology approvals, proving that the oncology pipeline is robust with first-of-the kind molecules, competitor products for existing agents, and biosimilars.

Oncology Pipeline Predictions 

Nearly 19% of U.S. adults have experienced some form of mental illness and over 4% have a serious mental illness, according to the National Institute of Mental Health (NIMH)

Medicines are one part of a personalized treatment plan for mental illness. However, according to the NIMH, it often takes time and patience to find a combination of therapies that work best for each patient.

“A great challenge in treatment is that patients often experience more than one psychological issue-for example, schizophrenia, depression and substance abuse,” says Jennifer Seagle, PharmD, area clinical manager for CompleteRx. “It is not uncommon to see patients on multiple treatment agents, which all have the potential to interact with each other-or other medical treatments-and potentially exacerbate their comorbidities, cause excessive sedation, or have unwanted side effects.”

Several different classes of medications are used to treat mental illnesses and not all therapies work the same in every patient.

“The current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) manual does not provide treatment recommendations. Likewise, many mental health guidelines don’t recommend one class of agents over another for treatment of patients with mental health disorders, nor do they recommend a specific agent in a class, as exemplified by the APA guidelines on Major Depressive Disorder,” Seagle says. “There is also a distinct lack of data to support superior efficacy amongst antipsychotics for conditions such as schizophrenia and bipolar 1 disorder, apart from clozapine in treatment-resistant patients. Providers must consider side-effect profiles, patient preference, compliance issues and cost when selecting therapy.” 

One trend Seagle is seeing is increased use of newer antipsychotics such as lurasidone (Latuda) and iloperidone (Fanapt) competing with much less-costly agents that have gone generic such as risperidone (Risperdal) and quetiapine (Seroquel).”

For patients where adherence or taking oral medications is an issue, there are several long-acting antipsychotic injectables available on the market, Seagle says. “These come with a hefty price tag and cost may be an issue for patients as well as the challenge prescribers would face titrating doses, as often these are weekly or monthly injections.”

Medicines in Development for Mental Illnesses 2017 Report

,” more than 140 medicines to treat mental illness are in development.

ALKS-5461 (Alkermes), a novel, once-daily oral agent for depression combines buprenorphine and samidorphan. It is in clinical trials and under review by the FDA. Alkermes has another candidate, ALKS 3831, a novel combination (samidorphan, olanzapine) antipsychotic that is expected to reduce the metabolic adverse events and weight gain associated with usual treatments, Seagle says. 

Other potential pipeline therapies listed in the PhRMA report include an intranasal drug in development for treatment-resistant depression and a subcutaneous, long-acting formulation of buprenorphine for opioid use disorder.

“I expect we will see new combination products as well as agents that have longer frequencies, allowing for fewer administrations each month to address compliance issues known to be problematic in these patient populations,” Seagle says. “We will be watchful to see agents that reduce the adverse events associated with these therapies- metabolic, weight gain, extrapyramidal symptoms, etc.”

Erin Bastick, PharmD, RPh, is staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio

Not all therapies work the same in every patient, but that’s not the biggest challenge in treating mental health. This is.

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The number of Americans who believe vaccinations for diseases like measles and polio are crucial to public health has fallen 10% in the last 10 years (from 80% to 70%), according to a new survey from Research America.

The findings should be concerning for healthcare executives, not only due to the impact non-vaccinations can have on patients, but also due to the high cost.

The economic burden of diseases associated with 10 vaccines recommended by the CDC for adults was $8.95 billion, and unvaccinated people were responsible for almost 80% of that burden ($7.1 billion), according to a 

“Immunizations protect the public from serious diseases and assist in preventing illnesses, disabilities, and even deaths,” says Jennifer Seagle, PharmD, area clinical manager for CompleteRx. “Vaccines, when utilized, have the power to greatly reduce the financial burden on the healthcare global economy.”

Here are three vaccine developments that have far reaching implications.

Shingrix (GlaxoSmithKline), a recombinant zoster vaccine approved by the FDA in October 2017, has replaced Zostavax as the CDC’s preferred vaccine for the prevention of shingles in healthy adults 50 years and older. Shingrix is given as a two-dose series separated by two to six months and costs about $280 per two dose-series compared to $213 for a single Zostavax vaccine. In clinical trials, the efficacy of Shingrix topped 96.6% for adults 50 to 69 years old for prevention of shingles, but that fell to 92.3% in those older than 70.

The World Health Organization (WHO) along with other international health agencies including the Global Alliance for Rabies Control, developed the ‘Zero by 30’ initiative in 2015 with the goal to provide a common strategy to achieve zero human rabies deaths by 2030. The initiative focuses on improving access to vaccinations for bite victims, providing education on bite prevention and expanding dog vaccination coverage to reduce human exposure.

The Advisory Committee on Immunization Practice recommends annual influenza vaccination for all persons aged 6 months and older who do not have contraindications. According to the CDC, vaccine composition is reviewed annually through year-round surveillance in more than 100 national influenza centers around the world, after which the WHO makes recommendations on the composition of the influenza vaccine for each year. Overall vaccine effectiveness against influenza A-the predominant strain of influenza this season-was estimated at 25% as of February 15, 2018. The WHO made its recommendations in February for the strains to target for the 2018 to 2019 vaccine.

There are currently 214 vaccines in the pipeline worldwide, says Seagle. “Of those, 40 agents solely prevent influenza. Many vaccines are important during different stages of life and health insurers need to take this into account as they design plans.”

Two vaccines in development could greatly benefit public health. The first is a vaccine in phase 2 clinical trials for the prevention of 

 infections in patients who are undergoing pre-surgical prophylaxis for elected orthopedic surgery. The second is a vaccine in development for HIV that could be made available as early as 2020.

Erin Bastick, PharmD, RPh, is staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.

Vaccines are an important part of creating “herd immunity” to keep infectious diseases in check. Here are three vaccine developments that have far reaching implications for public health.