Optimer Pharmaceuticals, Inc., a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products, has received new technology add-on payment (NTAP) for Dificid tablets from the Centres for Medicare & Medicaid Services (CMS) to administer in the inpatient setting to treat Clostridium difficile-associated diarrhoea (CDAD).

Introduced in 2001, the CMS NTAP programme is designed to support timely access of innovative therapies used to treat Medicare beneficiaries in the inpatient setting.

The NTAP programme is only available to new technologies demonstrating a substantial clinical improvement and meeting specific cost thresholds. The NTAP payment will provide hospitals with a payment, in addition to the standard-of-care DRG reimbursement, of up to 50 per cent of the cost of Dificid for a period of two to three years, effective in the fiscal year starting on October 1, 2012. For 2013, CMS has assigned a maximum payment of $868.00. The NTAP payment is available to hospitals only for individual patient cases that are more costly than the average DRG charges.

In the final rule concerning Hospital Inpatient Prospective Payment Systems and Fiscal Year 2013, (scheduled for publication in the Federal Register on August 31, 2012), CMS states that: “After reviewing the totality of the evidence and the public comments we received, we agree with the commenters that Dificid (Fidaxomicin) represents a substantial clinical improvement over existing technologies. We believe that Dificid represents a treatment option with the potential to decrease hospitalizations and physician office visits, and reduce the recurrence of CDAD, as well as to improve the quality of life for patients who have been diagnosed with CDAD.”

“The new technology add-on payment is important to enhancing the Medicare population's access to innovative treatments in the hospital in-patient setting, and we expect the additional reimbursement for Dificid through the NTAP programme will help defray the incremental cost of Dificid borne by hospitals," said Pedro Lichtinger, president and CEO of Optimer Pharmaceuticals. "The aggregate hospital costs for all C. difficile infections in the US exceed $8 billion. It's clear that CDAD, the most common symptom of CDI, has become a serious burden on the health care system."

Clostridium difficile infection (CDI) is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhoea and, in the most serious cases, death. Clostridium difficile-associated diarrhoea is the most common symptom of CDI. In recent years, C. difficile has surpassed methicillin-resistant Staphylococcus aureus (MRSA) as the leading cause of healthcare-acquired infections in community hospitals. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish.

The incidence, mortality and medical care costs of CDI have reached historic highs.  Over the past decade, the incidence of CDI has increased five-fold in North America and eight-fold in the elderly. CDI is a significant burden on the US healthcare system. In 2009, the aggregate cost for all CDI stays in hospitals was $8.2 billion, or 2.3 per cent of all hospital costs in the US. In the same year, 2009, the Medicare system was responsible for about 230,000 hospital based cases of CDI.

DIFICID is the first macrolide antibacterial drug indicated for CDAD to be approved in over 25 years in the US. It is indicated for the treatment of CDAD in adults 18 years of age or older. Dificid is administered in 200 mg tablets given orally twice daily.

Dificid should not be used for systemic infections. Only use Dificid for infection proven or strongly suspected to be caused by C. difficile. Prescribing Dificid in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11 per cent), vomiting (seven per cent), abdominal pain (six per cent), gastrointestinal haemorrhage (four per cent), anaemia (two per cent) and neutropenia (two per cent).