Ms. Amy Cairns reports

(PR)ELIDEL (PIMECROLIMUS) CREAM NOW REIMBURSED UNDER ALBERTA'S PUBLIC DRUG PLAN FOR ELIGIBLE PATIENTS WITH MILD TO MODERATE ATOPIC DERMATITIS

Bausch Health Canada Inc., a subsidiary of Bausch Health Companies Inc., has noted that PrElidel (pimecrolimus) cream is now listed under Alberta's public drug plan for eligible patients.

Elidel cream is indicated for second-line therapy for short-term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients three months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

Elidel has been available by prescription in Canada since 2003. The product is already reimbursed under several public drug plans across Canada, including those in British Columbia, Saskatchewan, Ontario and Quebec. With Alberta now adding coverage, more patients will have access to this treatment option.

"We are delighted that public reimbursement in Alberta will enable more patients living with atopic dermatitis to access Elidel. Improving access to treatment is critical to helping patients better manage their medical condition, while supporting improved health outcomes," said Amy Cairns, general manager, Bausch Health Canada.

"The reimbursement of Elidel in Alberta is fantastic news for patients living with atopic dermatitis," said Dr. Jessica Asgarpour, MD, FRCPC, FAAD, DABD, dermatologist at the Skin Health and Wellness Centre in Calgary, Alta. "Greater access to a topical non-corticosteroid treatment option will help physicians tailor therapy to individual patient needs and expand treatment choices for patients seeking alternatives to topical corticosteroids."

About atopic dermatitis

Atopic dermatitis is a chronic, relapsing and remitting inflammatory skin disease commonly encountered by primary-care providers. It affects all ages. In infants, onset occurs most often between three and six months. In children and teenagers, the estimated prevalence is 10 to 15 per cent. About 40 per cent of these continue to be affected as adults. About 85 per cent of all patients have mild to moderate disease.

Elidel clinical data and safety information

Elidel cream should be used in accordance with the Canadian product monograph. Please consult the product monograph for complete information on indications, contraindications, warnings and precautions, adverse reactions, drug interactions, dosing and administration.

Elidel cream is contraindicated in individuals with known or suspected hypersensitivity to pimecrolimus or any component of the cream. Elidel should not be applied to areas of active cutaneous viral infections, and clinical infections at treatment sites should be cleared before treatment. Patients should minimize or avoid exposure to natural or artificial sunlight while using Elidel.

Vehicle-controlled studies in pediatrics

Two identical six-week, randomized, vehicle-controlled, multicentre, phase 3 trials were conducted to evaluate Elidel cream 1 per cent for the treatment of mild to moderate eczema (atopic dermatitis). A total of 403 pediatric patients two to 18 years old were included in the studies. The male/female ratio was approximately 50 per cent and 29 per cent of the patients were African American. At study entry, 59 per cent of patients had moderate disease and the mean body surface area (BSA) affected was 26 per cent. About 75 per cent of patients had atopic dermatitis affecting the face and/or neck region.

In these studies, patients applied either Elidel cream or vehicle cream twice daily to 5 per cent to 96 per cent of their BSA for up to six weeks. At end point, based on the physician's global evaluation of clinical response, 35 per cent of patients treated with Elidel cream were clear or almost clear of signs of atopic dermatitis compared with only 18 per cent of vehicle treated patients. More Elidel patients (57 per cent) had mild or no pruritus at six weeks compared with vehicle patients (34 per cent). The improvement in pruritus occurred in conjunction with the improvement of the patients' atopic dermatitis.

In these two six-week studies of Elidel, the combined efficacy results at endpoint are as shown in the attached table.

In the two pediatric studies that independently support the use of Elidel cream in mild to moderate atopic dermatitis, a significant treatment effect was seen by day 15. Of the key signs of atopic dermatitis, erythema, infiltration/papulation, lichenification and excoriations, erythema and infiltration/papulation were reduced at day 8 when compared with vehicle.

Active-comparative controlled study in pediatrics

A five-year, multicentre, open-label, parallel group, randomized study was conducted to demonstrate the safety of Elidel cream (twice daily) compared with topical corticosteroids (TCS) in the treatment of infants three months to less than 12 months of age at enrolment with mild to moderate atopic dermatitis (AD):

• When used for six weeks during the acute state of the disease by assessing adverse events (AEs);
• When used for up to five years by assessing AEs and any potential effect on the developing immune system and growth velocity;
• To document the long-term efficacy of Elidel cream in the treatment of mild to moderate AD for up to five years (no statistical testing of efficacy was planned).

The facial investigator's global assessment (IGA) rating was severe or very severe for 24 (1.0 per cent) patients. The majority of patients (2,415 patients, 99.9 per cent) had an overall IGA rating of mild or moderate disease. Baseline disease characteristics of patients in the immunology/safety set and follow-up/safety set were similar to those for the safety set.

Efficacy results: Over all, the efficacy parameters in the Elidel treatment group in infants three to less than 12 months of age (at start of study) were similar to that observed in the topical corticosteroids (TCS) treatment group.

• At three weeks and six weeks of treatment (acute phase), overall IGA treatment success was achieved in more than 50 per cent of patients in both treatment groups, and facial IGA treatment success was achieved in greater than or equal to 61 per cent of patients in both treatment groups. By the end of the fifth year of treatment, treatment success was still demonstrated among patients who remained in the trial.
• The total body surface area (TBSA) affected by AD decreased with both treatments in a similar manner throughout the study. The mean TBSA affected at baseline was approximately 21 per cent in both treatment groups and decreased to less than 10 per cent by week six (acute phase) and was sustained to the end of five years in patients who remained in the trial for both treatment groups.

Overall conclusions: Elidel cream was efficacious and well tolerated in subjects with mild to moderate AD who were three to 12 months of age at the start of the study. No impairment of systemic immune assessments was seen, and subjects with AD who were treated with Elidel cream or TCS displayed normal immune response maturation and developed effective immunization against vaccine antigens.

About Bausch Health Companies Inc.

Bausch Health Companies is a global, diversified pharmaceutical company enriching lives through the company's relentless drive to deliver better health care outcomes. The company develops, manufactures and markets a range of products primarily in gastroenterology, hepatology, neuroscience, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through the company's controlling interest in Bausch + Lomb Corp. The company's ambition is to be a globally integrated health care company, trusted and valued by patients, HCPs (health care practitioners), employees and investors.

The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, chronic weight management, allergy, neuroscience and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Que., and Steinbach, Man.

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