New Vaccines Cost More

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VACCINES MAY BE LOW VOLUME now, but some experts believe that with current public health trends, they have the potential to become a bigger portion of the pharmaceutical spend. A look at the specialty pharmacy market highlights the similarities between the two categories: as indications expand, use expands.

“In recent years, there are examples of vaccines that have shown this potential, including Prevnar and Gardasil—medications that initially were for younger people but are now in wider use within older populations,” according to Jagannath M. Muzumdar, doctoral candidate, College of Pharmacy, University of Minnesota, Minneapolis.

Vaccines are one of the most cost-effective achievements in medicine because they not only protect people who are immunized but also protect the spread of the disease, providing a herd immunity effect, according to Muzumdar. Payers almost unanimously provide coverage because of their cost-effectiveness. In fact, at press time, UnitedHealth Group said that it will cover the H1N1 vaccine for its members whose benefit plans cover vaccines and also cover the administration of the vaccine for members whose plans currently do not include immunizations.

To date, the major health impacts from vaccines have been in the prevention arena, according to Gregory A. Poland, MD, director, Mayo Vaccine Research Group, Rochester, Minn.

“In this regard, one can expect to see an increasing number of preventive vaccines for illnesses ranging from H1N1 influenza, to ear infections, to even dental cavities, as well as classical infectious diseases such as hepatitis C, HIV and rotavirus,” Dr. Poland says.

Most therapeutic vaccines remain in early-phase clinical trials. However, an effective vaccine for lung cancer could reach market in the next one to three years, according to ECRI Institute’s Health Technology Forecast. In its report, “Therapeutic Vaccines for Lung Cancer,” ECRI Institute reviewed preliminary results from ongoing trials released by four vaccine manufacturers. If those preliminary results are upheld and eventually result in approval by the Food and Drug Administration, ECRI Institute researchers anticipate that therapeutic cancer vaccines will be widely implemented into lung cancer treatment programs for carefully selected patients.

“If these vaccines follow suit with other types of therapeutic vaccines we’ve looked at, we expect that therapeutic lung cancer vaccines will be effective only in certain subgroups of lung cancer patients,” says Randall Hulshizer, MS, MA, senior clinical writer of ECRI Institute’s Health Technology Forecast. “But within those subgroups, they are likely to become a standard of care as adjuvant therapy for all stages of non-small cell lung cancer.”

In addition, ECRI Institute expects an increase in life expectancy and quality for patients who respond well to the vaccines and a decrease in overall costs of treatment, as the vaccines might reduce side effects and the amount of chemotherapy or radiation needed.

There is some limited use of vaccines in cancer therapy and diabetes, according to James Cross, MD, head of national medical policy and operations at Aetna.

“The spend for vaccines could definitely increase as more are developed for either prevention or treatment of diseases,” Dr. Cross says. “However, vaccines are probably the most effective and cost-effective way to manage disease that there is.”

Like many insurers, Aetna follows the recommendations of the government or specialty societies on the use of vaccines for both children and adults. The plan covers vaccines under its medical benefit, managing the cost through appropriate use, and through negotiated rates for the vaccine itself, Dr. Cross says.

PREVENTIVE VS. THERAPEUTIC

In terms of the preventive vaccines, as with most health plans and large medical groups, HealthPartners covers what the Advisory Committee on Immunization Practices (ACIP) recommends, although for the most part, “we cover vaccines as they come out, as we do our analysis,” says James Nordin, MD, MPH, head of the plan’s Disease Surveillance System and Influenza Immunization Program. Preventive vaccines have great potential use for adults. While he isn’t certain how HealthPartners will cover therapeutic vaccines, the plan is broaching that on a case-by-case basis.

“Therapeutic vaccines will require a somewhat different management system, as they will likely only be given for specific indications,” Dr. Nordin says. “I would expect this to involve input from the specialists who use the vaccines.”

He believes some will be cost effective. For instance, a vaccine against the HER2 antigen in some breast cancers will likely be as effective as Herceptin in reducing recurrences, but at a fraction of the cost of a year of Herceptin, he says.

CIGNA’s Doug Hadley, MD, medical director and head of the plan’s coverage policy unit doesn’t see vaccines becoming either a bigger or a smaller portion of total pharmaceutical spend.

“While it’s true that vaccines have grown in recent years, and cover more diseases, so have alternative biologicals,” Dr. Hadley says. “But vaccines are becoming more costly and this is creating challenges for physicians to stock and inventory them.”

Health plans that are managing vaccines are also allocating resources toward the data-mining aspects, according to Ruth Ann Opdycke, Pharm D, MS, president, TPG Healthcare Consulting LLC.

“They are then taking this as an additional step to consolidate the medical and pharmacy benefit vaccine utilization from a data, benefit-analysis and management perspective,” Opdycke says.

Identifying this kind of data is critical to health plans looking to ensure that the needs of all members are met. For example, vaccines are no longer simply for children and adolescents as new innovations are bringing a wide range of vaccines to a broad range of patients. Health plans increasingly are the focal point for ensuring their members receive necessary vaccines. However, there are challenges with this new charge.

Historically, the focus has been on childhood vaccinations for traditional managed care, both coverage and adherence to established administration protocols, says F. Randy Vogenberg, RPh, PhD, executive director, Biologic Finance and Access Council, Thomas Jefferson University.

“For Medicare, similar adherence and claims data is not consistent due to older adult vaccines available through multiple sites or alternative channels with inconsistent claims tracking,” Vogenberg says. “In general, we’re not good at tracking all immunizations by patients over their lifetime. In the future, EMR/PHR systems will make this more likely.”

The lack of real-time medical claims adjudication in the provider’s office limits most of their ability to intervene while the patient is in the office to drive high adult immunization rates.

“Even e-prescribing initiatives will be challenged to prospectively monitor and apply clinical protocols for vaccines covered under the medical benefits administered in a provider’s office,” Opdycke says. “As more vaccines are released, and e-prescribing becomes a standard workflow of the office-based practice, moving the coverage of office-based injectables from the medical benefit to the pharmacy benefit will facilitate real-time application of clinical protocols.”